Sample records for medical imaging devices

Mobile devices have fundamentally changed personal computing, with many people forgoing the desktop and even laptop computer altogether in favor of a smaller, lighter, and cheaper device with a touch screen. Doctors and patients are beginning to expect medicalimages to be available on these devices for consultative viewing, if not actual diagnosis. However, this raises serious concerns with regard to the ability of existing mobile devices and networks to quickly and securely move these images. Medicalimages often come in large sets, which can bog down a network if not conveyed in an intelligent manner, and downloaded data on a mobile device are highly vulnerable to a breach of patient confidentiality should that device become lost or stolen. Some degree of regulation is needed to ensure that the software used to view these images allows all relevant medical information to be visible and manipulated in a clinically acceptable manner. There also needs to be a quality control mechanism to ensure that a device's display accurately conveys the image content without loss of contrast detail. Furthermore, not all mobile displays are appropriate for all types of images. The smaller displays of smart phones, for example, are not well suited for viewing entire chest radiographs, no matter how small and numerous the pixels of the display may be. All of these factors should be taken into account when deciding where, when, and how to use mobile devices for the display of medicalimages. PMID:25467905

Handheld devices such as mobile phones and tablet computers have become widespread with thousands of available software applications. Recently, handhelds are being proposed as part of medicalimaging solutions, especially in emergency medicine, where immediate consultation is required. However, handheld devices differ significantly from medical workstation displays in terms of display characteristics. Moreover, the characteristics vary significantly among device types. We investigate the image quality characteristics of various handheld devices with respect to luminance response, spatial resolution, spatial noise, and reflectance. We show that the luminance characteristics of the handheld displays are different from those of workstation displays complying with grayscale standard target response suggesting that luminance calibration might be needed. Our results also demonstrate that the spatial characteristics of handhelds can surpass those of medical workstation displays particularly for recent generation devices. While a 5 mega-pixel monochrome workstation display has horizontal and vertical modulation transfer factors of 0.52 and 0.47 at the Nyquist frequency, the handheld displays released after 2011 can have values higher than 0.63 at the respective Nyquist frequencies. The noise power spectra for workstation displays are higher than 1.2×10−5 mm2 at 1 mm−1, while handheld displays have values lower than 3.7×10−6 mm2. Reflectance measurements on some of the handheld displays are consistent with measurements for workstation displays with, in some cases, low specular and diffuse reflectance coefficients. The variability of the characterization results among devices due to the different technological features indicates that image quality varies greatly among handheld display devices. PMID:24236113

Microbial biofilm is a colony of single bacteria cells (planktonic) that attached to surfaces, attract other microorganisms to attach and grow, and together they build an extracellular matrix composed of polysaccharides, protein, and DNA. Eventually, some cells will detach and spread to other surface. Biofilm on medicaldevices can cause severe infection to all age ranges from infant to adult. Therefore, it is important to detect biofilm in a fast and efficient manner. Hyperspectral imaging was utilized for distinguishing wide area of biofilm coverage on various materials and on different textures of stainless steeltest coupons. Not only is the coverage of biofilm important, but also the shear stress of biofilm on the attached surfaces is significant. This study investigates the effects of shear stress on the adhesion of biofilms on common medicaldevice surfaces such as glass, polycarbonate, polytetrafluoroethylene, and stainless steel with different textures. Biofilm was grown using Ps. aeruginosa and growth was monitored after 24 and 48 hours at 37° C. The coupons covered with biofilm were tilted at 45 degrees and 90 degrees for 30 seconds to induce shear stress and Hyperspectral images were taken. We hypothesize that stronger attachment on rough surface would be able to withstand greater shear stress compared to smooth surface.

The Food and Drug Administration (FDA) is classifying the ingestible telemetric gastrointestinal capsule imaging system device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the MedicalDevice Amendments of 1976 (the amendments), the Safe MedicalDevices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:11820252

The Digital Imaging and Communications in Medicine (DICOM) standard defines Radiology medicaldevice interoperability and image data exchange between modalities, image databases - Picture Archiving and Communication Systems (PACS) - and image review end-points. However the scope of DICOM and PACS technology is currently limited to the trusted and static environment of the hospital. In order to meet the demand for ad-hoc tele-radiology and image guided medical procedures within the global healthcare enterprise, a new technology must provide mobility, security, flexible scale of operations, and rapid responsiveness for DICOM medicaldevices and subsequently medicalimage data. Grid technology, an informatics approach to securely federate independently operated computing, storage, and data management resources at the global scale over public networks, meets these core requirements. Here we present an approach to federate DICOM and PACS devices for large-scale medicalimage workflows within a global healthcare enterprise. The Globus MEDICUS (MedicalImaging and Computing for Unified Information Sharing) project uses the standards-based Globus Toolkit Grid infrastructure to vertically integrate a new service for DICOM devices - the DICOM Grid Interface Service (DGIS). This new service translates between DICOM and Grid operations and thus transparently extends DICOM to Globus based Grid infrastructure. This Grid image workflow paradigm has been designed to provide not only solutions for global image communication, but fault-tolerance and disaster recovery using Grid data replication technology. Actual use-case of 40 MEDICUS Grid connected international hospitals of the Childerns Oncology Group and the Neuroblastoma Cancer Foundation and further clinical applications are discussed. The open-source Globus MEDICU http://dev.globus.org/wiki/Incubator/MEDICUS. PMID:17476069

With computing capability and display size growing, the mobile device has been used as a tool to help clinicians view patient information and medicalimages anywhere and anytime. It is uneasy and time-consuming for transferring medicalimages with large data size from picture archiving and communication system to mobile client, since the wireless network is unstable and limited by bandwidth. Besides, limited by computing capability, memory and power endurance, it is hard to provide a satisfactory quality of experience for radiologists to handle some complex post-processing of medicalimages on the mobile device, such as real-time direct interactive three-dimensional visualization. In this work, remote rendering technology is employed to implement the post-processing of medicalimages instead of local rendering, and a service protocol is developed to standardize the communication between the render server and mobile client. In order to make mobile devices with different platforms be able to access post-processing of medicalimages, the Extensible Markup Language is taken to describe this protocol, which contains four main parts: user authentication, medicalimage query/ retrieval, 2D post-processing (e.g. window leveling, pixel values obtained) and 3D post-processing (e.g. maximum intensity projection, multi-planar reconstruction, curved planar reformation and direct volume rendering). And then an instance is implemented to verify the protocol. This instance can support the mobile device access post-processing of medicalimage services on the render server via a client application or on the web page.

The editors introduce the Biomedical Optics Express feature issue on "Phantoms for the Performance Evaluation and Validation of Optical MedicalImagingDevices." This topic was the focus of a technical workshop that was held on November 7-8, 2011, in Washington, D.C. The feature issue includes 13 contributions from workshop attendees. PMID:22741084

A medicaldevice is any product used to diagnose, cure, or treat a condition, or to prevent disease. They range ... may need one in a hospital. To use medicaldevices safely Know how your device works. Keep instructions ...

A medicaldevice is any product used to diagnose, cure, or treat a condition, or to prevent disease. They ... may need one in a hospital. To use medicaldevices safely Know how your device works. Keep ...

Performing high quality 3D visualizations on mobile devices, while tantalizingly close in many areas, is still a quite difficult task. This is especially true for 3D volume rendering of digital medicalimages. Allowing this would empower medical personnel a powerful tool to diagnose and treat patients and train the next generation of physicians. This research focuses on performing real time volume rendering of digital medicalimages on iOS devices using custom developed GPU shaders for orthogonal texture slicing. An interactive volume renderer was designed and developed with several new features including dynamic modification of render resolutions, an incremental render loop, a shader-based clipping algorithm to support OpenGL ES 2.0, and an internal backface culling algorithm for properly sorting rendered geometry with alpha blending. The application was developed using several application programming interfaces (APIs) such as OpenSceneGraph (OSG) as the primary graphics renderer coupled with iOS Cocoa Touch for user interaction, and DCMTK for DICOM I/O. The developed application rendered volume datasets over 450 slices up to 50-60 frames per second, depending on the specific model of the iOS device. All rendering is done locally on the device so no Internet connection is required.

A terahertz (THz) imaging system and high efficient terahertz sources and detectors for medical applications were developed. A fiber laser based compact time domain terahertz tomography system was developed with a high depth resolution of less than 20 μm. Three-dimensional images of porcine skin were obtained including some physical properties such as applied skin creams. The discrimination between healthy human tissue and tumor tissue has been achieved using reflection spectra. To improve the THz imaging system, a ridge waveguide LiNbO3 based nonlinear terahertz generator was studied to achieve high output power. A ridge waveguide with 5-7 μm width was designed for high efficiency emission from the LiNbO3 crystal by the electro-optic Cherenkov effect. Terahertz electronic sources and detectors were also realized for future imaging systems. As electronic source devices, resonant tunneling diode (RTD) oscillators with a patch antenna were fabricated using an InGaAs/InAlAs/AlAs triple barrier structure. On the other side, Schottky barrier diode (SBD) detectors with a log-periodic antenna were fabricated by thin-film technology on a Si substrate. Both devices operate above 1 THz at room temperature. This electronic THz device set could provide a future high performance imaging system.

This article discusses principal concepts for the analysis, classification, and reporting of problems involving medicaldevice technology. We define a medicaldevice in regulatory terminology and define and discuss concepts and terminology used to distinguish the causes and sources of medicaldevice problems. Database classification systems for medicaldevice failure tracking are presented, as are sources of information on medicaldevice failures. The importance of near-accident reporting is discussed to alert users that reported medicaldevice errors are typically limited to those that have caused an injury or death. This can represent only a fraction of the true number of device problems. This article concludes with a summary of the most frequently reported medicaldevice failures by technology type, clinical application, and clinical setting. PMID:12400632

Discusses four main types of medicalimaging (x-ray, radionuclide, ultrasound, and magnetic resonance) and considers their relative merits. Describes important recent and possible future developments in image processing. (Author/MKR)

Contamination of the inner surface of indwelling (implanted) medicaldevices by microbial biofilm is a serious problem. Some microbial bacteria such as Escherichia coli form biofilms that lead to potentially life-threatening infections. Other types of medicaldevices such as bronchoscopes and duod...

In this presentation, as a member of the Harmonization by Doing (HBD) project, I discuss the significance of regulatory science in global medicaldevice development and our experience in the international collaboration process for medicaldevices. In Japan, most innovative medical therapeutic devices were previously developed and exported by foreign-based companies. Due to this device lag, Japanese had minimal opportunities for receiving treatment with innovative medicaldevices. To address this issue, the Japanese government has actively accepted foreign clinical trial results and promoted global clinical trials in projects such as HBD. HBD is a project with stakeholders from academia, regulatory authorities, and industry in the US and Japan to promote global clinical trials and reduce device lags. When the project started, medicaldevice clinical trials were not actively conducted in Japan at not just hospitals but also at medicaldevice companies. We started to identify issues under the concept of HBD. After 10 years, we have now become key members in global clinical trials and able to obtain approvals without delay. Recently, HBD has started promoting international convergence. Physicians and regulatory authorities play central roles in compiling guidelines for the clinical evaluation of medicaldevice development, which will be a more active field in the near future. The guidelines compiled will be confirmed with members of academia and regulatory authorities in the United Sates. PMID:27040333

Medicaldevices have been individualized to include a category of implantable medicaldevices, "designed to be totally implanted in the human body or to replace an epithelial surface or a surface of the eye, through surgery, and remain in place after the intervention" (directive 93/42/CEE and decree of 20 April 206). Each implantable medicaldevice has a common name and a commercial name for precise identification of the model (type/references). The users' service and the implanting physician should be clearly identified. There are a number of rules concerning health traceability to rapidly identify patients exposed to risks in which the implantable medicaldevices of a particular batch or series were used and to monitor the consequences. The traceability data should be preserved 10 years and the patient's medical file for 20 years. PMID:18442666

There are a number of medically related imaging programs at synchrotron facilities around the world. The most advanced of these are the dual energy transvenous coronary angiography imaging programs, which have progressed to human imaging for some years. The NSLS facility will be discussed and patient images from recent sessions from the NSLS and HASYLAB will be presented. The effort at the Photon Factory and Accumulator Ring will also be briefly covered, as well as future plans for the new facilities. Emphasis will be on the new aspects of these imaging programs; this includes imaging with a peripheral venous injection of the iodine contrast agent, imaging at three photon energies, and the potential of a hospital-based compact source. Other medical programs to be discussed, are the multiple energy computed tomography (MECT) project at the NSLS and plans for a MECT program at the ESRF. Recently, experiments performed at the NSLS to image mammography phantoms using monochromatic beam have produced very promising results. This program will be discussed as well as some new results from imaging a phantom using a thin Laue crystal analyzer after the object to eliminate scatter onto the detector. {copyright} {ital 1996 American Institute of Physics.}

The realization of image processing algorithms in a hybrid optoelectronic device is discussed. The linear part of the algorithm is carried out in the optical block, and the nonlinear part of the algorithm in the electronic processing block of the device. These studies indicate the expediency of using the optical methods for processing the images of medico-biological objects to facilitate their visual analysis. PMID:7321818

..., and metrics of body dose and peak skin dose are displayed to the operator(s) of the equipment and... devices, demonstrating dose reduction and image quality claims? If so, why, and what data should be..., operating principles for the technology, general information about optimizing patient dose and image...

We propose a quantification method called Mapped Average Principal Component Analysis Score (MAPS) to enumerate the contamination coverage on common medicaldevice surfaces. The method was adapted from conventional Principal Component Analysis (PCA) on non-overlapped regions on a full frame hyperspe...

The advanced technology of computing system was followed by the rapid improvement of medical instrumentation and patient record management system. The typical examples are hospital information system (HIS) and picture archiving and communication system (PACS), which computerized the management procedure of medical records and images in hospital. Because these systems were built and used in hospitals, doctors out of hospital have problems to access them immediately on emergent cases. To solve these problems, this paper addressed the realization of system that could transmit the images acquired by medicalimaging systems in hospital to the remote doctors' handheld PDA's using CDMA cellular phone network. The system consists of server and PDA. The server was developed to manage the accounts of doctors and patients and allocate the patient images to each doctor. The PDA was developed to display patient images through remote server connection. To authenticate the personal user, remote data access (RDA) method was used in PDA accessing the server database and file transfer protocol (FTP) was used to download patient images from the remove server. In laboratory experiments, it was calculated to take ninety seconds to transmit thirty images with 832 x 488 resolution and 24 bit depth and 0.37 Mb size. This result showed that the developed system has no problems for remote doctors to receive and review the patient images immediately on emergent cases. PMID:19058651

This thesis addresses the characterization of light scattering processes that degrade image quality in high performance electronic display devices for digital radiography. Using novel experimental and computational tools, we study the lateral diffusion of light in emissive display devices that causes extensive veiling glare and significant reduction of the physical contrast. In addition, we examine the deleterious effects of ambient light reflections that affect the contrast of low luminance regions, and superimpose unwanted structured signal. The analysis begins by introducing the performance limitations of the human visual system to define high fidelity requirements. It is noted that current devices severely suffer from image quality degradation due to optical transport processes. To model the veiling glare and reflectance characteristics of display devices, we introduce a Monte Carlo light transport simulation code, DETECT-II, that tracks individual photons through multiple scattering events. The simulation accounts for the photon polarization state at each scattering event, and provides descriptions for rough surfaces and thin film coatings. A new experimental method to measure veiling glare is described next, based on a conic collimated probe that minimizes contamination from bright areas. The measured veiling glare ratio is taken to be the luminance in the surrounding bright field divided by the luminance in the dark circle. We show that veiling glare ratios in the order of a few hundreds can be measured with an uncertainty of a few percent. The veiling glare response function is obtained by measuring the small spot contrast ratio of test patterns having varying dark spot radius. Using DETECT-II, we then estimate the ring response functions for a high performance medicalimaging monitor of current design, and compare the predictions of the model with the experimentally measured response function. The data presented in this thesis demonstrate that although

There is now a wide choice of medicalimaging to show both focal and diffuse pathologies in various organs. Conventional radiology with plain films, fluoroscopy and contrast medium have many advantages, being readily available with low-cost apparatus and a familiarity that almost leads to contempt. The use of plain films in chest disease and in trauma does not need emphasizing, yet there are still too many occasions when the answer obtainable from a plain radiograph has not been available. The film may have been mislaid, or the examination was not requested, or the radiograph had been misinterpreted. The converse is also quite common. Examinations are performed that add nothing to patient management, such as skull films when CT will in any case be requested or views of the internal auditory meatus and heal pad thickness in acromegaly, to quote some examples. Other issues are more complicated. Should the patient who clinically has gall-bladder disease have more than a plain film that shows gall-stones? If the answer is yes, then why request a plain film if sonography will in any case be required to 'exclude' other pathologies especially of the liver or pancreas? But then should cholecystography, CT or scintigraphy be added for confirmation? Quite clearly there will be individual circumstances to indicate further imaging after sonography but in the vast majority of patients little or no extra information will be added. Statistics on accuracy and specificity will, in the case of gall-bladder pathology, vary widely if adenomyomatosis is considered by some to be a cause of symptoms or if sonographic examinations 'after fatty meals' are performed. The arguments for or against routine contrast urography rather than sonography are similar but the possibility of contrast reactions and the need to limit ionizing radiation must be borne in mind. These diagnostic strategies are also being influenced by their cost and availability; purely pragmatic considerations are not

The US Food and Drug Administration (FDA) has defined a medicaldevice as a health care product that does not achieve it’s purpose by chemical action or by being metabolized. This means that a vast number of products are considered medicaldevices. Such devices play an essential role in the practice of medicine. The FDA classifies medicaldevices in three classes, depending on the risk of the device. Since Class I and II devices have relatively simple requirements for getting to the market, this review will focus on “implantable devices”, which, in general, belong to Class III. The European Union and Canada use a slightly different classification system. While early generations of medicaldevices were introduced without much testing, either technical or clinical, the process of introducing a Class III medicaldevice from concept to clinical practice has become strongly regulated and requires extensive technological and clinical testing. The modern era of implantable medicaldevices may be considered to have started in the 1920s with development of artificial hips. The implantable pacemaker was another milestone and pacemakers and cardioverters/defibrillators have since saved millions of lives and created commercial giants in the medicaldevice industry. This review will include some examples of cardiovascular devices. Similar considerations apply to the total implantable device market, although clinical and technological applications obviously vary considerably. PMID:24966699

This paper presents progress on imaging the research field of Imaging Informatics, mapped as the clustering of its communities together with their main results by applying a process to produce a dynamical image of the interactions between their results and their common object(s) of research. The basic side draws from a fundamental research on the concept of dimensions and projective space spanning several streams of research about three-dimensional perceptivity and re-cognition and on their relation and reduction to spatial dimensionality. The application results in an N-dimensional mapping in Bio-MedicalImaging, with dimensions such as inflammatory activity, MRI acquisition sequencing, spatial resolution (voxel size), spatiotemporal dimension inferred, toxicity, depth penetration, sensitivity, temporal resolution, wave length, imaging duration, etc. Each field is represented through the projection of papers' and projects' `discriminating' quantitative results onto the specific N-dimensional hypercube of relevant measurement axes, such as listed above and before reduction. Past published differentiating results are represented as red stars, achieved unpublished results as purple spots and projects at diverse progress advancement levels as blue pie slices. The goal of the mapping is to show the dynamics of the trajectories of the field in its own experimental frame and their direction, speed and other characteristics. We conclude with an invitation to participate and show a sample mapping of the dynamics of the community and a tentative predictive model from community contribution.

Teleconsultation of digital images among different medical centers is now a reality. The problem to be solved is how to interconnect all the clinical diagnostic devices in a hospital in order to allow physicians and health physicists, working in different places, to discuss on interesting clinical cases visualizing the same diagnostic images at the same time. Applying World Wide Web technologies, the proposed system can be easily used by people with no specific computer knowledge providing a verbose help to guide the user through the right steps of execution. Diagnostic images are retrieved from a relational database or from a standard DICOM-PACS through the DICOM-WWW gateway allowing connection of the usual Web browsers to DICOM applications via the HTTP protocol. The system, which is proposed for radiotherapy implementation, where radiographies play a fundamental role, can be easily converted to different field of medical applications where a remote access to secure data are compulsory.

An imagingdevice captures both a visible light image and a diagnostic image, the diagnostic image corresponding to emissions from an imaging medium within the object. The visible light image (which may be color or grayscale) and the diagnostic image may be superimposed to display regions of diagnostic significance within a visible light image. A number of imaging media may be used according to an intended application for the imagingdevice, and an imaging medium may have wavelengths above, below, or within the visible light spectrum. The devices described herein may be advantageously packaged within a single integrated device or other solid state device, and/or employed in an integrated, single-camera medicalimaging system, as well as many non-medicalimaging systems that would benefit from simultaneous capture of visible-light wavelength images along with images at other wavelengths.

Images are an integral part of medical practice for diagnosis, treatment planning and teaching. Image retrieval has gained in importance mainly as a research domain over the past 20 years. Both textual and visual retrieval of images are essential. In the process of mobile devices becoming reliable and having a functionality equaling that of formerly desktop clients, mobile computing has gained ground and many applications have been explored. This creates a new field of mobile information search & access and in this context images can play an important role as they often allow understanding complex scenarios much quicker and easier than free text. Mobile information retrieval in general has skyrocketed over the past year with many new applications and tools being developed and all sorts of interfaces being adapted to mobile clients. This article describes constraints of an information retrieval system including visual and textual information retrieval from the medical literature of BioMedCentral and of the RSNA journals Radiology and Radiographics. Solutions for mobile data access with an example on an iPhone in a web-based environment are presented as iPhones are frequently used and the operating system is bound to become the most frequent smartphone operating system in 2011. A web-based scenario was chosen to allow for a use by other smart phone platforms such as Android as well. Constraints of small screens and navigation with touch screens are taken into account in the development of the application. A hybrid choice had to be taken to allow for taking pictures with the cell phone camera and upload them for visual similarity search as most producers of smart phones block this functionality to web applications. Mobile information access and in particular access to images can be surprisingly efficient and effective on smaller screens. Images can be read on screen much faster and relevance of documents can be identified quickly through the use of images contained in

Scintillating materials are used in a variety of medicalimagingdevices. This paper presents a description of four medicalimaging modalities that make extensive use of scintillators: planar x-ray imaging, x-ray computed tomography (x-ray CT), SPECT (single photon emission computed tomography) and PET (positron emission tomography). The discussion concentrates on a description of the underlying physical principles by which the four modalities operate. The scintillator requirements for these systems are enumerated and the compromises that are made in order to maximize imaging performance utilizing existing scintillating materials are discussed, as is the potential for improving imaging performance by improving scintillator properties.

Modern medicine is an increasingly complex activity , based on the evidence ; it consists of information from multiple sources : medical record text , sound recordings , images and videos generated by a large number of devices . Medicalimaging is one of the most important sources of information since they offer comprehensive support of medical procedures for diagnosis and follow-up . However , the amount of information generated by image capturing gadgets quickly exceeds storage availability in radiology services , generating additional costs in devices with greater storage capacity . Besides , the current trend of developing applications in cloud computing has limitations, even though virtual storage is available from anywhere, connections are made through internet . In these scenarios the optimal use of information necessarily requires powerful compression algorithms adapted to medical activity needs . In this paper we present a review of compression techniques used for image storage , and a critical analysis of them from the point of view of their use in clinical settings. PMID:23715317

The MD Image System, a true-color image processing system that serves as a diagnostic aid and tool for storage and distribution of images, was developed by MedicalImage Management Systems, Huntsville, AL, as a "spinoff from a spinoff." The original spinoff, Geostar 8800, developed by Crystal Image Technologies, Huntsville, incorporates advanced UNIX versions of ELAS (developed by NASA's Earth Resources Laboratory for analysis of Landsat images) for general purpose image processing. The MD Image System is an application of this technology to a medical system that aids in the diagnosis of cancer, and can accept, store and analyze images from other sources such as Magnetic Resonance Imaging.

The Food and Drug Administration (FDA) is amending the medicaldevice tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA), and to simplify certain requirements. PMID:11838471

With China's growing old-age population and economic presence on the international stage, it has become important to evaluate its domestic and foreign market contribution to medicaldevices. Medicaldevices are instruments or apparatuses used in the prevention, rehabilitation, treatment, or knowledge generation with respect to disease or other abnormal conditions. This article provides information drawn from recent publications to describe the current state of the Chinese domestic market for medicaldevices and to define opportunities for foreign investment potential therein. Recent healthcare reforms implemented to meet rising demand due to an aging and migrating population are having a positive effect on market growth-a global market with a projected growth of 15% per year over the next decade. PMID:25735659

Hospital buyers of medicaldevices contract with manufacturers with market power that sell differentiated products. The medical staff strongly influences hospitals' choice of devices. Sellers have sought to limit disclosure of transaction prices. Policy-makers have proposed legislation mandating disclosure, in the interest of greater transparency. We discuss why a manufacturer might charge different prices to different hospitals, the role that secrecy plays, and the consequences of secrecy versus disclosure. We argue that hospital-physician relationships are key to understanding what manufacturers gain from price discrimination. Price disclosure can catalyze a restructuring of those relationships, which, in turn, can improve hospital bargaining. PMID:18997210

For companies seeking investors, money is available, but it is not as easy to obtain as it has been in recent years. Although the medicaldevice industry remains an attractive proposition, several factors have contributed to the downturn in public-offering investment. This article outlines these factors and discusses the types of medical technologies that are likely to attract investment in the immediate future. PMID:10146504

Image file format is often a confusing aspect for someone wishing to process medicalimages. This article presents a demystifying overview of the major file formats currently used in medicalimaging: Analyze, Neuroimaging Informatics Technology Initiative (Nifti), Minc, and Digital Imaging and Communications in Medicine (Dicom). Concepts common to all file formats, such as pixel depth, photometric interpretation, metadata, and pixel data, are first presented. Then, the characteristics and strengths of the various formats are discussed. The review concludes with some predictive considerations about the future trends in medicalimage file formats. PMID:24338090

Most digital imaging systems provide opportunities for image enhancement operations. These are applied to improve the original image and to make the image more appealing visually. One possible means of enhancing digital radiographic image is sharpening. The purpose of sharpening filters is to improve image quality by removing noise or edge enhancement. Sharpening filters may make the radiographic images subjectively more appealing. But during this process, important radiographic features may disappear while artifacts that simulate pathological process might be generated. Therefore, it is of utmost importance for dentists to be familiar with and aware of the use of image enhancement operations, provided by medical digital imaging programs. PMID:26255429

The regulation of mobile medicaldevices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medicaldevices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medicaldevices in China needs to adopt the risk-based method. PMID:26665948

The paper gives an introduction to current medical ultrasound imaging systems. The basics of anatomic and blood flow imaging are described. The properties of medical ultrasound and its focusing are described, and the various methods for two- and three-dimensional imaging of the human anatomy are shown. Systems using both linear and non-linear propagation of ultrasound are described. The blood velocity can also be non-invasively visualized using ultrasound and the basic signal processing for doing this is introduced. Examples for spectral velocity estimation, color flow imaging and the new vector velocity images are presented. PMID:17092547

A medicalimaging system provides simultaneous rendering of visible light and diagnostic or functional images. The system may be portable, and may include adapters for connecting various light sources and cameras in open surgical environments or laparascopic or endoscopic environments. A user interface provides control over the functionality of the integrated imaging system. In one embodiment, the system provides a tool for surgical pathology.

The prominent development of health technologies of the 20th century triggered demands for metrological reliability of physiological measurements comprising physical, chemical and biological quantities, essential to ensure accurate and comparable results of clinical measurements. In the present work, aspects concerning metrological reliability in premarket and postmarket assessments of medicaldevices are discussed, pointing out challenges to be overcome. In addition, considering the social relevance of the biomeasurements results, Biometrological Principles to be pursued by research and innovation aimed at biomedical applications are proposed, along with the analysis of their contributions to guarantee the innovative health technologies compliance with the main ethical pillars of Bioethics.

Therapeutic coatings on medicaldevices such as catheters, guide wires, and stents improve biocompatibility by favorably altering the chemical nature of the device/tissue or device/blood interface. Such coatings often minimize tissue damage (reduce friction), decrease chances for blood clot formation (prevent platelet adsorption), and improve the healing response (deliver drugs). Confocal Raman microscopy provides valuable information about biomedical coatings by, for example, facilitating the measurement of the thickness and swelling of frictionreducing hydrogel coatings on catheters and by determining the distribution of drug within a polymer-based drug-eluting coatings on stents. This chapter explores the application of Raman microscopy to the imaging of thin coatings of cross-linked poly(vinyl pyrrolidone) gels, parylene films, mixtures of dexamethasone with various polymethacrylates, and mixtures of rapamycin with hydrolysable (biodegradable) poly(lactide-co-glycolide) polymers. Raman microscopy measures the thickness and swelling of coatings, reveals the degree of mixing of drug and polymer, senses the hydrolysis of biodegradable polymers, and determines the polymorphic forms of drug present within thin therapeutic coatings on medicaldevices.

In this paper, a novel handheld 3D medical thermography system is introduced. The proposed system consists of a thermal-infrared camera, a color camera and a depth camera rigidly attached in close proximity and mounted on an ergonomic handle. As a practitioner holding the device smoothly moves it around the human body parts, the proposed system generates and builds up a precise 3D thermogram model by incorporating information from each new measurement in real-time. The data is acquired in motion, thus it provides multiple points of view. When processed, these multiple points of view are adaptively combined by taking into account the reliability of each individual measurement which can vary due to a variety of factors such as angle of incidence, distance between the device and the subject and environmental sensor data or other factors influencing a confidence of the thermal-infrared data when captured. Finally, several case studies are presented to support the usability and performance of the proposed system.

The Food and Drug Administration (FDA) has the authority under the Federal Food, Drug, and Cosmetic Act (FDCA) to regulate the labeling of all medicaldevices. This statement, however, is not as simple as it appears. The regulation of medicaldevice labels and labeling, closely linked to the advertisement of medicaldevices, is a dynamic area, and FDA is struggling to address the new issues that arise daily in this area. This article seeks to: 1) provide the background necessary to understand the current law and FDA's regulation of medicaldevices; 2) summarize the law and regulations governing medicaldevices; 3) define "intended use" and explain its importance; and 4) discuss several areas that are of particular interest to FDA, including promotion of uncleared or unapproved devices and uses, Internet promotion, press releases, and comparative claims. PMID:11824451

A medicalimaging system provides simultaneous rendering of visible light and fluorescent images. The system may employ dyes in a small-molecule form that remains in a subject's blood stream for several minutes, allowing real-time imaging of the subject's circulatory system superimposed upon a conventional, visible light image of the subject. The system may also employ dyes or other fluorescent substances associated with antibodies, antibody fragments, or ligands that accumulate within a region of diagnostic significance. In one embodiment, the system provides an excitation light source to excite the fluorescent substance and a visible light source for general illumination within the same optical guide that is used to capture images. In another embodiment, the system is configured for use in open surgical procedures by providing an operating area that is closed to ambient light. More broadly, the systems described herein may be used in imaging applications where a visible light image may be usefully supplemented by an image formed from fluorescent emissions from a fluorescent substance that marks areas of functional interest.

While an adverse event involving a medicaldevice is often ascribed to either user error or device failure, the causes are typically multifactorial. A number of incidents involving medicaldevices are explored using this approach to investigate the various causes of the incident and the protective barriers that minimised or prevented adverse consequences. User factors, including mistakes, omissions and lack of training, conspired with background factors--device controls and device design, storage conditions, hidden device damage and physical layout of equipment when in use--to cause the adverse events. Protective barriers that prevented or minimised the consequences included staff vigilance, operating procedures and alarms. PMID:12715578

There have been significant technological advances in imaging capability over the past 40 years. Medicalimaging capabilities have developed rapidly, along with technology development in computational processing speed and miniaturization. Moving to all-digital, the number of images that are acquired in a routine clinical examination has increased dramatically from under 50 images in the early days of CT and MRI to more than 500-1000 images today. The staggering number of images that are routinely acquired poses significant challenges for clinicians to interpret the data and to correctly identify the clinical problem. Although the time provided to render a clinical finding has not substantially changed, the amount of data available for interpretation has grown exponentially. In addition, the image quality (spatial resolution) and information content (physiologically-dependent image contrast) has also increased significantly with advances in medicalimaging technology. On its current trajectory, medicalimaging in the traditional sense is unsustainable. To assist in filtering and extracting the most relevant data elements from medicalimaging, image analytics will have a much larger role. Automated image segmentation, generation of parametric image maps, and clinical decision support tools will be needed and developed apace to allow the clinician to manage, extract and utilize only the information that will help improve diagnostic accuracy and sensitivity. As medicalimagingdevices continue to improve in spatial resolution, functional and anatomical information content, image/data analytics will be more ubiquitous and integral to medicalimaging capability.

The aim of this study is to provide emerging applications of wavelet methods to medical signals and images, such as electrocardiogram, electroencephalogram, functional magnetic resonance imaging, computer tomography, X-ray and mammography. Interpretation of these signals and images are quite important. Nowadays wavelet methods have a significant impact on the science of medicalimaging and the diagnosis of disease and screening protocols. Based on our initial investigations, future directions include neurosurgical planning and improved assessment of risk for individual patients, improved assessment and strategies for the treatment of chronic pain, improved seizure localization, and improved understanding of the physiology of neurological disorders. We look ahead to these and other emerging applications as the benefits of this technology become incorporated into current and future patient care. In this chapter by applying Fourier transform and wavelet transform, analysis and denoising of one of the important biomedical signals like EEG is carried out. The presence of rhythm, template matching, and correlation is discussed by various method. Energy of EEG signal is used to detect seizure in an epileptic patient. We have also performed denoising of EEG signals by SWT.

The aim of this study is to provide emerging applications of wavelet methods to medical signals and images, such as electrocardiogram, electroencephalogram, functional magnetic resonance imaging, computer tomography, X-ray and mammography. Interpretation of these signals and images are quite important. Nowadays wavelet methods have a significant impact on the science of medicalimaging and the diagnosis of disease and screening protocols. Based on our initial investigations, future directions include neurosurgical planning and improved assessment of risk for individual patients, improved assessment and strategies for the treatment of chronic pain, improved seizure localization, and improved understanding of the physiology of neurological disorders. We look ahead to these and other emerging applications as the benefits of this technology become incorporated into current and future patient care. In this chapter by applying Fourier transform and wavelet transform, analysis and denoising of one of the important biomedical signals like EEG is carried out. The presence of rhythm, template matching, and correlation is discussed by various method. Energy of EEG signal is used to detect seizure in an epileptic patient. We have also performed denoising of EEG signals by SWT.

According to the background of the age of big data, the medicaldevices are informatized, we analyze the safety and efficiency for the information and data of digital medicaldevices or medical systems, also discussed some test methods. Lack of a suitable standard system of digital medicaldevices is a big problem both for domain standard and international standard. GB25000.51 is too ambiguous and free for testing, also not very operational. So this paper suggested some test advices and some prospective method. These test methods are helpful for finding the problem and performing the standards. What's more, these methods are famous in the world and used widely in the 3C region but just start in the medical region, which can promote the development of the medicaldevices. PMID:25330611

We present a procedure to generate digital phantoms with a hyperspectral image projector (HIP) consisting of two liquid crystal on silicon (LCoS) spatial light modulators (SLMs). The digital phantoms are 3D image data cubes of the spatial distribution of spectrally resolved abundances of intracellular light-absorbing oxy-hemoglobin molecules in single erythrocytes. Spectrally and spatially resolved image data indistinguishable from the real scene may be used as standards to calibrate image sensors and validate image analysis algorithms for their measurement quality, performance consistency, and inter-laboratory comparisons for quantitative biomedical imaging applications.

MedicalDevices Law is a relatively new legal system, which has replaced the MedicalDevices Regulations still well-known in Germany. German MedicalDevices Law is based on European directives, which are, in turn, incorporated into national law by the MedicalDevices Act. The MedicalDevices Act is a framework law and covers a number of regulations that address specific topics within MedicalDevices Law. In turn, in individual regulations, reference is made to guidelines, recommendations, etc. from other sources that provide detailed technical information on specific topics. MedicalDevices Law is a very complex legal system, which needs to be permanently observed due to constant updating and adjustment. In the current article, the design and the structure of the system will be described, but special emphasis will be laid on important problem areas that need to be considered when applying and operating medical products, in this case by pain therapists in particular. PMID:27333770

Implantable medicaldevices are becoming more pervasive as new technologies increase their reliability and safety. Furthermore, these devices are becoming increasingly reliant on wireless communication for interaction with the device. Such technologies have the potential to leak information that could be utilized by an attacker to threaten the lives of patients. Privacy of patient information is essential; however, this information is not the only privacy issue that must be considered. In this paper, we discuss why information privacy is insufficient for protecting patients from some attacks and how information regarding the presence of individual devices can leak vulnerabilities. Furthermore, we examine existing privacy enhancing algorithms and discuss their applicability to implantable medicaldevices.

Just as much as healthcare information systems, medicaldevices need protection against cybersecurity threats. Anti-malware software can help safeguard the devices in your facility-but it has limitations and even risks. Find out what steps you can take to manage anti-malware applications in your devices. PMID:21306047

The popularity of digital imagingdevices and PACS installations has increased during the last years. Still, images are analyzed and diagnosed using conventional techniques. Our research group begun to study the requirements for digital image diagnostic methods to be applied together with PACS systems. The research was focused on various image analysis procedures (e.g., segmentation, volumetry, 3D visualization, image fusion, anatomic atlas, etc.) that could be useful in medical diagnosis. We have developed Image Analysis software (www.medimag.net) to enable several image-processing applications in medical diagnosis, such as volumetry, multimodal visualization, and 3D visualizations. We have also developed a commercial scalable image archive system (ActaServer, supports DICOM) based on component technology (www.acta.fi), and several telemedicine applications. All the software and systems operate in NT environment and are in clinical use in several hospitals. The analysis software have been applied in clinical work and utilized in numerous patient cases (500 patients). This method has been used in the diagnosis, therapy and follow-up in various diseases of the central nervous system (CNS), respiratory system (RS) and human reproductive system (HRS). In many of these diseases e.g. Systemic Lupus Erythematosus (CNS), nasal airways diseases (RS) and ovarian tumors (HRS), these methods have been used for the first time in clinical work. According to our results, digital diagnosis improves diagnostic capabilities, and together with PACS installations it will become standard tool during the next decade by enabling more accurate diagnosis and patient follow-up.

Over the past century technology has played a decisive role in defining, driving, and reinventing procedures, devices, and pharmaceuticals in healthcare. Cloud computing has been introduced only recently but is already one of the major topics of discussion in research and clinical settings. The provision of extensive, easily accessible, and reconfigurable resources such as virtual systems, platforms, and applications with low service cost has caught the attention of many researchers and clinicians. Healthcare researchers are moving their efforts to the cloud, because they need adequate resources to process, store, exchange, and use large quantities of medical data. This Vision 20/20 paper addresses major questions related to the applicability of advanced cloud computing in medicalimaging. The paper also considers security and ethical issues that accompany cloud computing. PMID:23822402

To improve the quality of photos sent to Earth by unmanned spacecraft. NASA's Jet Propulsion Laboratory (JPL) developed a computerized image enhancement process that brings out detail not visible in the basic photo. JPL is now applying this technology to biomedical research in its Medical lrnage Analysis Facility, which employs computer enhancement techniques to analyze x-ray films of internal organs, such as the heart and lung. A major objective is study of the effects of I stress on persons with heart disease. In animal tests, computerized image processing is being used to study coronary artery lesions and the degree to which they reduce arterial blood flow when stress is applied. The photos illustrate the enhancement process. The upper picture is an x-ray photo in which the artery (dotted line) is barely discernible; in the post-enhancement photo at right, the whole artery and the lesions along its wall are clearly visible. The Medical lrnage Analysis Facility offers a faster means of studying the effects of complex coronary lesions in humans, and the research now being conducted on animals is expected to have important application to diagnosis and treatment of human coronary disease. Other uses of the facility's image processing capability include analysis of muscle biopsy and pap smear specimens, and study of the microscopic structure of fibroprotein in the human lung. Working with JPL on experiments are NASA's Ames Research Center, the University of Southern California School of Medicine, and Rancho Los Amigos Hospital, Downey, California.

People with diabetes should always wear a medical alert bracelet or necklace that emergency medical workers will ... People with diabetes should always wear a medical alert bracelet or necklace that emergency medical workers will ...

Active implantable medicaldevice develops rapidly in recent years. The clinical demands and current application are introduced, the technical trends are discussed, and the safety risks are analyzed in this paper. PMID:24409793

Anesthesiologists are unique among most physicians in that they routinely use technology and medicaldevices to carry out their daily activities. Recently, there have been significant advances in medical technology. These advances have increased the number and utility of medicaldevices available to the anesthesiologist. There is little doubt that these new tools have improved the practice of anesthesia. Monitoring has become more comprehensive and less invasive, airway management has become easier, and placement of central venous catheters and regional nerve blockade has become faster and safer. This review focuses on key medicaldevices such as cardiovascular monitors, airway equipment, neuromonitoring tools, ultrasound, and target controlled drug delivery software and hardware. This review demonstrates how advances in these areas have improved the safety and efficacy of anesthesia and facilitate its administration. When applicable, indications and contraindications to the use of these novel devices will be explored as well as the controversies surrounding their use. PMID:24707188

Anesthesiologists are unique among most physicians in that they routinely use technology and medicaldevices to carry out their daily activities. Recently, there have been significant advances in medical technology. These advances have increased the number and utility of medicaldevices available to the anesthesiologist. There is little doubt that these new tools have improved the practice of anesthesia. Monitoring has become more comprehensive and less invasive, airway management has become easier, and placement of central venous catheters and regional nerve blockade has become faster and safer. This review focuses on key medicaldevices such as cardiovascular monitors, airway equipment, neuromonitoring tools, ultrasound, and target controlled drug delivery software and hardware. This review demonstrates how advances in these areas have improved the safety and efficacy of anesthesia and facilitate its administration. When applicable, indications and contraindications to the use of these novel devices will be explored as well as the controversies surrounding their use. PMID:24707188

Wirelessly enabling MedicalDevices such as Vital Signs Monitors, Ventilators and Infusion Pumps allows central data collection. This paper discusses how data from these types of devices can be integrated into hospital systems using wireless sensor networking technology. By integrating devices you are protecting investment and opening up the possibility of networking with similar devices. In this context we present how Zigbee meets our requirements for bandwidth, power, security and mobility. We have examined the data throughputs for various medicaldevices, the requirement of data frequency, security of patient data and the logistics of moving patients while connected to devices. The paper describes a new tested architecture that allows this data to be seamlessly integrated into a User Interface or Healthcare Information System (HIS). The design supports the dynamic addition of new medicaldevices to the system that were previously unsupported by the system. To achieve this, the hardware design is kept generic and the software interface for different types of medicaldevices is well defined. These devices can also share the wireless resources with other types of sensors being developed in conjunction on this project such as wireless ECG (Electrocardiogram) and Pulse-Oximetry sensors. PMID:18003568

A handheld ultrasound imagingdevice, one that weighs less than five pounds, has been developed for diagnosing trauma in the combat battlefield as well as a variety of commercial mobile diagnostic applications. This handheld device consists of four component ASICs, each is designed using the state of the art microelectronics technologies. These ASICs are integrated with a convex array transducer to allow high quality imaging of soft tissues and blood flow in real time. The device is designed to be battery driven or ac powered with built-in image storage and cineloop playback capability. Design methodologies of a handheld device are fundamentally different to those of a cart-based system. As system architecture, signal and image processing algorithm as well as image control circuit and software in this device is deigned suitably for large-scale integration, the image performance of this device is designed to be adequate to the intent applications. To elongate the battery life, low power design rules and power management circuits are incorporated in the design of each component ASIC. The performance of the prototype device is currently being evaluated for various applications such as a primary image screening tool, fetal imaging in Obstetrics, foreign object detection and wound assessment for emergency care, etc.

People with diabetes should always wear a medical alert bracelet or necklace that emergency medical workers will be able to find. Medical identification products can help ensure proper treatment in an ...

The present invention relates to an apparatus for producing sterile ice slurries for medical cooling applications. The apparatus is capable of producing highly loaded slurries suitable for delivery to targeted internal organs of a patient, such as the brain, heart, lungs, stomach, kidneys, pancreas, and others, through medical size diameter tubing. The ice slurry production apparatus includes a slurry production reservoir adapted to contain a volume of a saline solution. A flexible membrane crystallization surface is provided within the slurry production reservoir. The crystallization surface is chilled to a temperature below a freezing point of the saline solution within the reservoir such that ice particles form on the crystallization surface. A deflector in the form of a reciprocating member is provided for periodically distorting the crystallization surface and dislodging the ice particles which form on the crystallization surface. Using reservoir mixing the slurry is conditioned for easy pumping directly out of the production reservoir via medical tubing or delivery through other means such as squeeze bottles, squeeze bags, hypodermic syringes, manual hand delivery, and the like.

Two fields of radiology, medicalimaging and radiation therapy, are coded separately in medical fee system, and the health care statistics of 2003 shows that expenditure on the former was 5.2% of the whole medical cost and the latter 0.28%. Introduction of DPC, an abbreviation of Diagnostic Procedure Combination, was carried out in 2003, which was an essential reform of medical fee payment system that have been managed on fee-for-service base throughout, and 22% of beds for acute patients care are under the control of DPC payment in 2006. As medicalimaging procedures are basically classified in inclusive payment in DPC system, their accurate statistics cannot be figured out because of the lack of description of individual procedures in DPC bills. Policy-making of medical economics will suffer a great loss from the deficiency of detailed data in published statistics. Important role in clinical diagnoses of CT and MR results an increase of fee paid for them up to more than half of total expenditure on medicalimaging. So, dominant reduction of examination fee has been done for MR imaging, especially in 2002, to reduce the total cost of medicalimaging. Follows could be featured as major topics of medicalimaging in health insurance system, (a) fee is newly assigned for electronic handling of CT-and-MR images, and nuclear medicine, and (b) there is still a mismatch between actual payment and quality of medical facilities. As matters related to medicalimaging, the followings should be stressed; (a) numbers of CT and MR units per population are dominantly high among OECD countries, but, those controlled by qualified radiologists are at the average level of those countries, (b) there is a big difference of MR examination quality among medical facilities, and (c) 76% of newly-installed high-end MR units are supplied by foreign industries. Hopefully, there will be an increase in the concern to medical fee payment system and health care cost because they possibly

The rapid advancements in high performance global communication have accelerated cooperative image-based medical services to a new frontier. Traditional image-based medical services such as radiology and diagnostic consultation can now fully utilize multimedia technologies in order to provide novel services, including remote cooperative medical triage, distributed virtual simulation of operations, as well as cross-country collaborative medical research and training. Fast (efficient) and easy (flexible) retrieval of relevant images remains a critical requirement for the provision of remote medical services. This paper describes the database system requirements, identifies technological building blocks for meeting the requirements, and presents a system architecture for our target image database system, MISSION-DBS, which has been designed to fulfill the goals of Project MISSION (medicalimaging support via satellite integrated optical network) -- an experimental high performance gigabit satellite communication network with access to remote supercomputing power, medicalimage databases, and 3D visualization capabilities in addition to medical expertise anywhere and anytime around the country. The MISSION-DBS design employs a synergistic fusion of techniques in distributed databases (DDB) and artificial intelligence (AI) for storing, migrating, accessing, and exploring images. The efficient storage and retrieval of voluminous image information is achieved by integrating DDB modeling and AI techniques for image processing while the flexible retrieval mechanisms are accomplished by combining attribute- based and content-based retrievals.

We have developed a protocol to evaluate the magnetic resonance (MR) compatibility of implantable medicaldevices. The testing protocol consists of the evaluation of magnetic field-induced movement, electric current, heating, image distortion, and device operation. In addition, current induction is evaluated with a finite element analysis simulation technique that models the effect of radiofrequency fields on each device. The protocol has been applied to several implantable infusion pumps and neurostimulators with associated attachments. Experiments were performed using a 1.5-T whole-body MR system with parameters selected to approximate the intended clinical and worst case configuration. The devices exhibited moderate magnetic field-induced deflection and torque but had significant image artifacts. No heating was detected for any of the devices. Pump operation was halted in the magnetic field, but resumed after removed. Exposure to the magnetic field activated some of the neurostimulators. PMID:10232520

Medicaldevice software is a special kind of medicaldevice, which is different from hardware and may introduce more risk. How to reduce the risk of software efficiently is the important thing for medicaldevice regulation system. This article analyzes medicaldevice software's properties, introduces the status of foreign supervision, and finally gives some advises to the related parties. PMID:21954581

Hyperspectral imaging (HSI) is an emerging imaging modality for medical applications, especially in disease diagnosis and image-guided surgery. HSI acquires a three-dimensional dataset called hypercube, with two spatial dimensions and one spectral dimension. Spatially resolved spectral imaging obtained by HSI provides diagnostic information about the tissue physiology, morphology, and composition. This review paper presents an overview of the literature on medical hyperspectral imaging technology and its applications. The aim of the survey is threefold: an introduction for those new to the field, an overview for those working in the field, and a reference for those searching for literature on a specific application.

Abstract. Hyperspectral imaging (HSI) is an emerging imaging modality for medical applications, especially in disease diagnosis and image-guided surgery. HSI acquires a three-dimensional dataset called hypercube, with two spatial dimensions and one spectral dimension. Spatially resolved spectral imaging obtained by HSI provides diagnostic information about the tissue physiology, morphology, and composition. This review paper presents an overview of the literature on medical hyperspectral imaging technology and its applications. The aim of the survey is threefold: an introduction for those new to the field, an overview for those working in the field, and a reference for those searching for literature on a specific application. PMID:24441941

Accurate segmentation of medicalimages is a key step in contouring during radiotherapy planning. Computed topography (CT) and Magnetic resonance (MR) imaging are the most widely used radiographic techniques in diagnosis, clinical studies and treatment planning. This review provides details of automated segmentation methods, specifically discussed in the context of CT and MR images. The motive is to discuss the problems encountered in segmentation of CT and MR images, and the relative merits and limitations of methods currently available for segmentation of medicalimages. PMID:20177565

... the Orthopaedic and Rehabilitation Devices Panel of the MedicalDevices Advisory Committee. Submit... INFORMATION: Name of Committee: Orthopaedic and Rehabilitation Devices Panel of the MedicalDevices Advisory... with or considering hip replacement (...

Apparatus for detecting and locating a source of gamma rays of energies ranging from 10-20 keV to several MeV's includes plural gamma ray detectors arranged in a generally closed extended array so as to provide Compton scattering imaging and coded aperture imaging simultaneously. First detectors are arranged in a spaced manner about a surface defining the closed extended array which may be in the form a circle, a sphere, a square, a pentagon or higher order polygon. Some of the gamma rays are absorbed by the first detectors closest to the gamma source in Compton scattering, while the photons that go unabsorbed by passing through gaps disposed between adjacent first detectors are incident upon second detectors disposed on the side farthest from the gamma ray source, where the first spaced detectors form a coded aperture array for two or three dimensional gamma ray source detection.

...This document contains proposed regulations that provide guidance on the excise tax imposed on the sale of certain medicaldevices under section 4191 of the Internal Revenue Code, enacted by the Health Care and Education Reconciliation Act of 2010 in conjunction with the Patient Protection and Affordable Care Act. The proposed regulations affect manufacturers, importers, and producers of......

Electron beam radiation is used in the sterilisation of medical disposable devices. High energy, 10 MeV, electron beam linear accelerators are in use worldwide for this purpose. The dose distribution achieved in the products treated influences the efficiency of treatment. This paper looks at the dose distribution achieved with such machines and the methods used to define it in heterogeneous products.

The United States' medicaldevice color additive regulations are unknown to some, and confusing to many. This article reviews statutory language on color additives in the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, including the Delaney Clause on carcinogenicity; color additive regulatory language as it relates to medicaldevices in Title 21 of the Code of Federal Regulations (C.F.R.), Parts 70-82; reports on the Food and Drug Administration's (FDA's) likely current and historical practices in dealing with color additives in medicaldevices; and speculates on what may have given rise to decades of seemingly ad hoc color additives practices, which may now be difficult to reconstruct and satisfactorily modify. Also addressed is the Center for Devices and Radiological Health's (CDRH's) recent publicly-vetted approach to color additives in Section 7 of its April 2013 draft guidance, Use of International Standard ISO-10993, "Biological Evaluation of MedicalDevices Part 1: Evaluation and Testing," which the author concludes is a change in the right direction, but which, at least in its current draft form, is not a fix to the CDRH's color additives dilemma. Lastly, the article suggests what the CDRH might consider in further developing a new approach to color additives. Such an approach would treat color additives as if they were any other potentially toxic group of chemicals, and could be fashioned in such a way that the CDRH could still satisfy the broad aspects of Congressional color additives mandates, and.yet be consistent with ISO 10993. In doing this, the CDRH would need to recommend a more directed use of its Quality System Regulation, 21 C.F.R. Part 820, for material and vendor qualification and validation in general; approach Congress for needed statutory changes; or make administrative changes. In order for any approach to be successful, whether it is a new twist on past practices, or an entirely new path forward, the FDA must, to the best of its

Deformable image registration is a fundamental task in medicalimage processing. Among its most important applications, one may cite: i) multi-modality fusion, where information acquired by different imagingdevices or protocols is fused to facilitate diagnosis and treatment planning; ii) longitudinal studies, where temporal structural or anatomical changes are investigated; and iii) population modeling and statistical atlases used to study normal anatomical variability. In this paper, we attempt to give an overview of deformable registration methods, putting emphasis on the most recent advances in the domain. Additional emphasis has been given to techniques applied to medicalimages. In order to study image registration methods in depth, their main components are identified and studied independently. The most recent techniques are presented in a systematic fashion. The contribution of this paper is to provide an extensive account of registration techniques in a systematic manner. PMID:23739795

Although there are many commercially available medical-grade adhesives, their use for new applications requires detailed investigation. It is also important that as well as the initial joint strength, durability of the bonded components during intended use, including exposure to low and high temperatures, stress, fluids and sterilisation, are investigated. Design of accelerated ageing tests, which can simulate the service environments, is critical in providing realistic durability data. Interpretation of ageing data and lifetime prediction of the joint is essential in assessing the performance of medicaldevices. Emergence of new types of adhesives as well as further development of precision dispensing and rapid-curing technologies offer many exciting and commercially attractive opportunities for joining medicaldevices. PMID:12397833

wireless communication eliminates obtrusive cables associated with wearable sensors and considerably increases patient comfort during measurement and collection of medical data. Wireless communication is very popular in recent years and plays a significant role in telemedicine and homecare applications. Bluetooth technology is one of the most commonly used wireless communication types in medicine. This paper describes the design of a universal wireless communication device with excellent price/performance ratio. The said device is based on the low-cost RN4020 Bluetooth module with Microchip Low-energy Data Profile (MLDP) and due to low-power consumption is especially suitable for the transmission of biological signals (ECG, EMG, PPG, etc.) from wearable medical/personal health devices. A unique USB dongle adaptor was developed for wireless communication via UART interface and power consumption was evaluated under various conditions.

The Food and Drug Administration (FDA) is classifying the medical washer and medical washer-disinfector intended for general medical purposes to clean and dry surgical instruments, decontaminate or disinfect anesthesia equipment, hollowware, and other medicaldevices into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors" (the guidance) as the special control that, in addition to general controls, the agency believes will reasonably ensure the safety and effectiveness of the device. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the MedicalDevice Amendments of 1976 (the 1976 amendments), the Safe MedicalDevices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (the FDAMA). PMID:12437015

Medicaldevice epidemiology is the study of the prevalence and incidence of use, effectiveness, and adverse events associated with medicaldevices in a population. The identification of large data sources with medicaldevice data provides a large population for epidemiologic studies. Two challenges in medicaldevice epidemiology are the ability to find data on the specific device and the exposure of a patient to that device. This paper identifies data sources both from the govenment and from the private sector that can be used for epidemiologic studies of medicaldevices and, to a limited degree, studies of medicaldevices in women. Each source provides data for different types of devices and in differing specificity. The paper also discusses briefly the strengths and weaknesses of each data source. More data sources are needed to enhance the study of medicaldevice epidemiology. Additional efforts and focus are needed to enhance the ability to study medicaldevices in women. PMID:12071476

The promise of compressive sensing, exploitation of compressibility to achieve high quality image reconstructions with less data, has attracted a great deal of attention in the medicalimaging community. At the Compressed Sensing Incubator meeting held in April 2014 at OSA Headquarters in Washington, DC, presentations were given summarizing some of the research efforts ongoing in compressive sensing for x-ray computed tomography and magnetic resonance imaging systems. This article provides an expanded version of these presentations. Sparsity-exploiting reconstruction algorithms that have gained popularity in the medicalimaging community are studied, and examples of clinical applications that could benefit from compressive sensing ideas are provided. The current and potential future impact of compressive sensing on the medicalimaging field is discussed. PMID:25968400

Implantable medicaldevices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health). In this review paper, methodologies to transfer and harvest energy in implantable medicaldevices are introduced and discussed to highlight the uses and significances of various potential power sources. PMID:26580626

Implantable medicaldevices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health). In this review paper, methodologies to transfer and harvest energy in implantable medicaldevices are introduced and discussed to highlight the uses and significances of various potential power sources. PMID:26580626

It is widely understood why medicaldevices need to be regulated by the FDA and other governing bodies. However medical software does not typically require the same level of regulation. Currently the FDA is investigating whether one type of medical software, MedicalDevice Data Systems (MDDS), should require FDA clearance because of the potential risk they impose when interconnected with medicaldevices. Hospitals are looking to implement MDDS because the technology allows nursing staff to spend more time on direct patient care and reduces charting errors. This article will explore the FDA's proposal and will review the possible risks and provide a rationale for why MDDS should be regulated by the FDA and why MDDS vendors should have the right level of quality and risk management procedures in place to ensure that they are developing and bringing to market the safest products possible. PMID:20677470

Since 1983, the American College of Radiology (ACR) and the National Electrical Manufacturers Association (NEMA) have been engaged in developing standards related to medicalimaging. This alliance of users and manufacturers was formed to meet the needs of the medicalimaging community as its use of digital imaging technology increased. The development of electronic picture archiving and communications systems (PACS), which could connect a number of medicalimagingdevices together in a network, led to the need for a standard interface and data structure for use on imaging equipment. Since medicalimage files tend to be very large and include much text information along with the image, the need for a fast, flexible, and extensible standard was quickly established. The ACR-NEMA Digital Imaging and Communications Standards Committee developed a standard which met these needs. The standard (ACR-NEMA 300-1988) was first published in 1985 and revised in 1988. It is increasingly available from equipment manufacturers. The current work of the ACR- NEMA Committee has been to extend the standard to incorporate direct network connection features, and build on standards work done by the International Standards Organization in its Open Systems Interconnection series. This new standard, called Digital Imaging and Communication in Medicine (DICOM), follows an object-oriented design methodology and makes use of as many existing internationally accepted standards as possible. This paper gives a brief overview of the requirements for communications standards in medicalimaging, a history of the ACR-NEMA effort and what it has produced, and a description of the DICOM standard.

This paper introduces the premarket registration procedures and the post market regulatory requirements in India. According to Indian medicaldevice act and related medical regulations on medicaldevice, this is a preliminary discussion on the registration management system to provide referance for foreign medicaldevice to enter India market. PMID:27197502

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medicaldevices; expiration of exemptions. 801.127... (CONTINUED) MEDICALDEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medicaldevices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medicaldevices; expiration of exemptions. 801.127... (CONTINUED) MEDICALDEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medicaldevices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medicaldevices; expiration of exemptions. 801.127... (CONTINUED) MEDICALDEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medicaldevices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medicaldevices; expiration of exemptions. 801.127... (CONTINUED) MEDICALDEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medicaldevices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medicaldevices; expiration of exemptions. 801.127... (CONTINUED) MEDICALDEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medicaldevices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

Open-source hardware is hardware whose design is made publicly available so anyone can study, modify, distribute, make and sell the design or the hardware based on that design. Some open-source hardware projects can potentially be used as active medicaldevices. The open-source approach offers a unique combination of advantages, including reducing costs and faster innovation. This article compares 10 of open-source healthcare projects in terms of how easy it is to obtain the required components and build the device. PMID:27158528

A barrier at a uniform depth for an entire wafer is used to produce imagingdevices less susceptible to noise pulses produced by the passage of ionizing radiation. The barrier prevents charge created in the bulk silicon of a CCD detector or a semiconductor logic or memory device from entering the collection volume of each pixel in the imagingdevice. The charge barrier is a physical barrier, a potential barrier, or a combination of both. The physical barrier is formed by an SiO{sub 2} insulator. The potential barrier is formed by increasing the concentration of majority carriers (holes) to combine with the electron`s generated by the ionizing radiation. A manufacturer of CCD imagingdevices can produce radiation-tolerant devices by merely changing the wafer type fed into his process stream from a standard wafer to one possessing a barrier beneath its surface, thus introducing a very small added cost to his production cost. An effective barrier type is an SiO{sub 2} layer. 7 figs.

A barrier at a uniform depth for an entire wafer is used to produce imagingdevices less susceptible to noise pulses produced by the passage of ionizing radiation. The barrier prevents charge created in the bulk silicon of a CCD detector or a semiconductor logic or memory device from entering the collection volume of each pixel in the imagingdevice. The charge barrier is a physical barrier, a potential barrier, or a combination of both. The physical barrier is formed by an SiO.sub.2 insulator. The potential barrier is formed by increasing the concentration of majority carriers (holes) to combine with the electron's generated by the ionizing radiation. A manufacturer of CCD imagingdevices can produce radiation-tolerant devices by merely changing the wafer type fed into his process stream from a standard wafer to one possessing a barrier beneath its surface, thus introducing a very small added cost to his production cost. An effective barrier type is an SiO.sub.2 layer.

... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the MedicalDevices Advisory... MedicalDevices Advisory Committee. This meeting was announced in the Federal Register of February 7, 2011... meeting of the Neurological Devices Panel of the MedicalDevices Advisory Committee would be held on...

Dealing with the difficulties of integrating various medicalimage viewing and processing technologies with a variety of clinical and departmental information systems and, in the meantime, overcoming the performance constraints in transferring and processing large-scale and ever-increasing image data in healthcare enterprise, we design and implement a flexible, usable and high-performance architecture for medicalimage workstations. This architecture is not developed for radiology only, but for any workstations in any application environments that may need medicalimage retrieving, viewing, and post-processing. This architecture contains an infrastructure named Memory PACS and different kinds of image applications built on it. The Memory PACS is in charge of image data caching, pre-fetching and management. It provides image applications with a high speed image data access and a very reliable DICOM network I/O. In dealing with the image applications, we use dynamic component technology to separate the performance-constrained modules from the flexibility-constrained modules so that different image viewing or processing technologies can be developed and maintained independently. We also develop a weakly coupled collaboration service, through which these image applications can communicate with each other or with third party applications. We applied this architecture in developing our product line and it works well. In our clinical sites, this architecture is applied not only in Radiology Department, but also in Ultrasonic, Surgery, Clinics, and Consultation Center. Giving that each concerned department has its particular requirements and business routines along with the facts that they all have different image processing technologies and image display devices, our workstations are still able to maintain high performance and high usability.

The computerization of the clinical record and the realization of the multimedia have brought improvement of the medical service in medical facilities. It is very important for the patients to obtain comprehensible informed consent. Therefore, the doctor should plainly explain the purpose and the content of the diagnoses and treatments for the patient. We propose and design a Telemedicine Imaging Collaboration System which presents a three dimensional medicalimage as X-ray CT, MRI with stereoscopic image by using virtual common information space and operating the image from a remote location. This system is composed of two personal computers, two 15 inches stereoscopic parallax barrier type LCD display (LL-151D, Sharp), one 1Gbps router and 1000base LAN cables. The software is composed of a DICOM format data transfer program, an operation program of the images, the communication program between two personal computers and a real time rendering program. Two identical images of 512×768 pixcels are displayed on two stereoscopic LCD display, and both images show an expansion, reduction by mouse operation. This system can offer a comprehensible three-dimensional image of the diseased part. Therefore, the doctor and the patient can easily understand it, depending on their needs.

A method and apparatus for determining the distribution of a position-emitting radioisotope into an object, the apparatus consisting of a wire mesh radiation converter, an ionizable gas for propagating ionization events caused by electrodes released by the converter, a drift field, a spatial position detector and signal processing circuitry for correlating near-simultaneous ionization events and determining their time differences, whereby the position sources of back-to-back collinear radiation can be located and a distribution image constructed.

... HUMAN SERVICES Food and Drug Administration Gastroenterology and Urology Devices Panel of the Medical... Devices Panel of the MedicalDevices Advisory Committee. General Function of the Committee: To provide... related to medicaldevices intended for obese patients. The committee will provide...

Programmable, implantable and external biomedical devices (such as pacemakers, defibrillators, insulin pumps, pain management pumps, vagus nerve stimulators and others) may be vulnerable to unauthorized access, commonly referred to as hacking. This intrusion may lead to compromise of confidential patient data or loss of control of the device itself, which may be deadly. Risks to health from unauthorized access is in addition to hazards from faulty (buggy) software or circuitry. Historically, this aspect of medicaldevice design has been underemphasized by both manufacturers and regulatory bodies until recently. However, an insulin pump was employed as a murder weapon in 2001 and successful hacking of an implantable defibrillator was demonstrated in 2008. To remedy these problems, professional groups have announced a variety of design standards and the governmental agencies of several countries have enacted device regulations. In turn, manufacturers have developed new software products and hardware circuits to assist biomedical engineering firms to improve their commercial offerings. In this paper the author discusses these issues, reviewing known problems and zero-day threats, with potential solutions. He outlines his approach to secure software and hardware challenges using the Forth language. A plausible scenario is described in which hacking of an implantable defibrillator by terrorists results in a severe national security threat to the United States. PMID:23686179

Systems, methods and devices are implemented for microscope imaging solutions. One embodiment of the present disclosure is directed toward an epifluorescence microscope. The microscope includes an image capture circuit including an array of optical sensor. An optical arrangement is configured to direct excitation light of less than about 1 mW to a target object in a field of view of that is at least 0.5 mm.sup.2 and to direct epi-fluorescence emission caused by the excitation light to the array of optical sensors. The optical arrangement and array of optical sensors are each sufficiently close to the target object to provide at least 2.5 .mu.m resolution for an image of the field of view.

In medical diagnosis of superficial lesions at inner or outer surfaces of the human body fluorescence imaging techniques are able to deliver additional information on the metabolic and structural state of the observed tissue. To subtract background fluorescence and to achieve a differential diagnosis a multispectral analysis in several wavelength windows is needed. Additionally, special image algorithms have to be applied which depend on the examined malignancy. For this purpose a multispectral fluorescence imagingdevice was developed. It can be used both endoscopically and in combination with a standard operational microscope from Carl Zeiss, Germany. In this paper, the device and first clinical results are presented. The device was built to detect superficial lesions like tumors, inflammations, etc. Target chromophores are NADH, Protoporphyrin IX, collagen and other. The measured optical bands are (405 plus or minus 5) nm, (442 plus or minus 5) nm, (458 plus or minus 5) nm, (550 plus or minus 5) nm, (630 plus or minus 5) nm and (690 plus or minus 5) nm. A special UV-source with a liquid light guide is used as the illumination source in two excitation bands of (365 plus or minus 10) nm and (420 plus or minus 20) nm. First clinical investigations of superficial malignancies like squamous cell carcinoma and basalioma are presented.

Certain exemplary embodiments comprise a system, which can comprise an imaging plate. The imaging plate can be exposable by an x-ray source. The imaging plate can be configured to be used in digital radiographic imaging. The imaging plate can comprise a phosphor-based image storage device configured to convert an image stored therein into light.

Integrated microbatteries have been proposed to satisfy an anticipated need for long-life, low-rate primary batteries, having volumes less than 1 mm3, to power electronic circuitry in implantable medicaldevices. In one contemplated application, such a battery would be incorporated into a tubular hearing-aid device to be installed against an eardrum. This device is based on existing tube structures that have already been approved by the FDA for use in human ears. As shown in the figure, the battery would comprise a single cell at one end of the implantable tube. A small volume of Li-based primary battery cathode material would be compacted and inserted in the tube near one end, followed by a thin porous separator, followed by a pressed powder of a Li-containing alloy. Current-collecting wires would be inserted, with suitably positioned insulators to prevent a short circuit. The battery would contain a liquid electrolyte consisting of a Li-based salt in an appropriate solvent. Hermetic seals would be created by plugging both ends with a waterproof polymer followed by deposition of parylene.

Abstract. Image resolution enhancement is a problem of considerable interest in all medicalimaging modalities. Unlike general purpose imaging or video processing, for a very long time, medicalimage resolution enhancement has been based on optimization of the imagingdevices. Although some recent works purport to deal with image postprocessing, much remains to be done regarding medicalimage enhancement via postprocessing, especially in ultrasound imaging. We face a resolution improvement issue in the case of medical ultrasound imaging. We propose to investigate this problem using multidimensional autoregressive (AR) models. Noting that the estimation of the envelope of an ultrasound radio frequency (RF) signal is very similar to the estimation of classical Fourier-based power spectrum estimation, we theoretically show that a domain change and a multidimensional AR model can be used to achieve super-resolution in ultrasound imaging provided the order is estimated correctly. Here, this is done by means of a technique that simultaneously estimates the order and the parameters of a multidimensional model using relevant regression matrix factorization. Doing so, the proposed method specifically fits ultrasound imaging and provides an estimated envelope. Moreover, an expression that links the theoretical image resolution to both the image acquisition features (such as the point spread function) and a postprocessing feature (the AR model) order is derived. The overall contribution of this work is threefold. First, it allows for automatic resolution improvement. Through a simple model and without any specific manual algorithmic parameter tuning, as is used in common methods, the proposed technique simply and exclusively uses the ultrasound RF signal as input and provides the improved B-mode as output. Second, it allows for the a priori prediction of the improvement in resolution via the knowledge of the parametric model order before actual processing. Finally, to achieve

One of the greatest difficulties of dealing with medicalimages is their distinct characteristics, in terms of generation process and noise that requires different forms of treatment for visualization and processing. Besides that, medicalimages are only a compounding part of the patient"s history, which should be accessible for the user in an understandable way. Other factors that can be used to enhance the user capability and experience are: the computational power of the client machine; available knowledge about the case; if the access is local or remote and what kind of user is accessing the system (physician, nurse, administrator, etc...). These information compose the context of an application and should define its behavior during execution time. In this article, we present the architecture of a viewer that takes into account the contextual information that is present at the moment of execution. We also present a viewer of X-Ray Angiographic images that uses contextual information about the client's hardware and the kind of user to, if necessary, reduce the image size and hide demographic information of the patient. The proposed architecture is extensible, allowing the inclusion of new tools and viewers, being adaptive along time to the evolution of the medical systems.

For development rational evaluation method for medicaldevices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medicaldevice under development should be conducted as well as its technological development. Clinical performance of a medicaldevice is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medicaldevice is accepted. Setting of appropriate end points is required to evaluate a medicaldevice appropriately. Risk assessment and risk management are the basis of medicaldevice safety assurance. In case of medicaldevice software, there are difficulties in identifying the risk due to its complexity of user environment and different design and manufacturing procedure compared with conventional hardware based medicaldevices. Recent technological advancement such as information and communication technologies (ICT) for medicaldevices and wireless network has raised new issue on risk management: cybersecurity. We have to watch closely the progress of safety standard development. PMID:26736611

Catheters and other interventional medicaldevices are presently guided by X-ray imaging, despite the advantages of ultrasound imaging over X-ray imaging in cost, safety, and availability. X-ray imaging is used because ultrasound reflects specularly from catheters and similar devices; their visibility is highly angle-dependent. With an omni-directional receiver mounted on a device, the receiver's location in the ultrasound image can be deduced from knowing which acoustic ray struck the receiver and the time from transmission of the imaging pulse to its reception by the receiver. This information is independent of specular reflection. The location of the device can then be indicated in the ultrasound image by an arrow pointing to the sensor, making possible ultrasound guidance of these devices. This paper describes the technical and practical considerations in the design and construction of the device-mounted receiver and associated electronics, and describes some clinical uses. PMID:18244147

Since the introduction of hyperpolarized 3He and 129Xe as gaseous MRI contrast agents more than a decade ago, a rich variety of imaging techniques and medical applications have been developed. Magnetic resonance imaging of the inhaled gas depicts ventilated lung airspaces with unprecedented detail, and allows one to track airflow and pulmonary mechanics during respiration. Information about lung structure and function can also be obtained using the physical properties of the gas, including spin relaxation in the presence of oxygen, restricted diffusion inside the alveolar airspaces, and the NMR frequency shift of xenon dissolved in blood and tissue.

Metal Injection moulding (MIM) is an advanced near net shape forming process. This paper presents the attempt to manufacture medicaldevices particularly fracture fixation plates for orthopedic applications for commercial purposes by MIM process. The stainless steel powder with the median particle size of 15 μm and a binder consisting of polyethylene, paraffin wax and stearic acid were mixed at 160° C using a sigma-blade mixer for one hour to prepare the feedstock of the fracture fixation plates. The fracture fixation plate component was injection molded using vertical injection moulding machine with the nozzle temperature of 200° C. Prior to sintering, the specimens were debound using a combination of solvent extraction and thermal pyrolysis method. The specimens were then sintered under vacuum. The properties of the fracture fixation plates such as physical and mechanical properties were presented and discussed. The in-vitro biocompatibility study on the fracture plates produced was examined.

An evolving area of biomedical research is related to the creation of implantable units that provide various possibilities for imaging, measurement, and the monitoring of a wide range of diseases and intrabody phototherapy. The units can be autonomic or built-in in some kind of clinically applicable implants. Because of specific working conditions in the live body, such implants must have a number of features requiring further development. This topic can cause wide interest among developers of optical, mechanical, and electronic solutions in biomedicine. We introduce preliminary clinical trials obtained with an implantable pill and devices that we have developed. The pill and devices are capable of applying in-body phototherapy, low-level laser therapy, blue light (450 nm) for sterilization, and controlled injection of chemicals. The pill is also capable of communicating with an external control box, including the transmission of images from inside the patient’s body. In this work, our pill was utilized for illumination of the sinus-carotid zone in dog and red light influence on arterial pressure and heart rate was demonstrated. Intrabody liver tissue laser ablation and nanoparticle-assisted laser ablation was investigated. Sterilization effect of intrabody blue light illumination was applied during a maxillofacial phlegmon treatment. PMID:25279540

An evolving area of biomedical research is related to the creation of implantable units that provide various possibilities for imaging, measurement, and the monitoring of a wide range of diseases and intrabody phototherapy. The units can be autonomic or built-in in some kind of clinically applicable implants. Because of specific working conditions in the live body, such implants must have a number of features requiring further development. This topic can cause wide interest among developers of optical, mechanical, and electronic solutions in biomedicine. We introduce preliminary clinical trials obtained with an implantable pill and devices that we have developed. The pill and devices are capable of applying in-body phototherapy, low-level laser therapy, blue light (450 nm) for sterilization, and controlled injection of chemicals. The pill is also capable of communicating with an external control box, including the transmission of images from inside the patient's body. In this work, our pill was utilized for illumination of the sinus-carotid zone in dog and red light influence on arterial pressure and heart rate was demonstrated. Intrabody liver tissue laser ablation and nanoparticle-assisted laser ablation was investigated. Sterilization effect of intrabody blue light illumination was applied during a maxillofacial phlegmon treatment.

We present a medicalimage and medical record database for the storage, research, transmission, and evaluation of medicalimages. Medicalimages from any source that supports the DICOM standard can be stored and accessed, as well as associated analysis and annotations. Retrieval is based on patient info, date, doctor's annotations, features in the images, or a spatial combination. This database supports the secure transmission of sensitive data for tele-medicine and follows all HIPPA regulations. PMID:17238733

... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Microbiology Devices Panel of the MedicalDevices Advisory Committee; Notice of Meeting... the public. Name of Committee: Microbiology Devices Panel of the MedicalDevices Advisory...

... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the MedicalDevices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the MedicalDevices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the MedicalDevices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the MedicalDevices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the MedicalDevices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the MedicalDevices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the MedicalDevices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the MedicalDevices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the MedicalDevices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the MedicalDevices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

... HUMAN SERVICES Food and Drug Administration Radiological Devices Panel of the MedicalDevices Advisory...). The meeting will be open to the public. Name of Committee: Radiological Devices Panel of the MedicalDevices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the MedicalDevices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the MedicalDevices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

Historical reviews of PACS (picture archiving and communication system) and imaging informatics development from different points of view have been published in the past (Huang in Euro J Radiol 78:163-176, 2011; Lemke in Euro J Radiol 78:177-183, 2011; Inamura and Jong in Euro J Radiol 78:184-189, 2011). This retrospective attempts to look at the topic from a different angle by identifying certain basic medicalimaging inventions in the 1960s and 1970s which had conceptually defined basic components of PACS guiding its course of development in the 1980s and 1990s, as well as subsequent imaging informatics research in the 2000s. In medicalimaging, the emphasis was on the innovations at Georgetown University in Washington, DC, in the 1960s and 1970s. During the 1980s and 1990s, research and training support from US government agencies and public and private medicalimaging manufacturers became available for training of young talents in biomedical physics and for developing the key components required for PACS development. In the 2000s, computer hardware and software as well as communication networks advanced by leaps and bounds, opening the door for medicalimaging informatics to flourish. Because many key components required for the PACS operation were developed by the UCLA PACS Team and its collaborative partners in the 1980s, this presentation is centered on that aspect. During this period, substantial collaborative research efforts by many individual teams in the US and in Japan were highlighted. Credits are due particularly to the Pattern Recognition Laboratory at Georgetown University, and the computed radiography (CR) development at the Fuji Electric Corp. in collaboration with Stanford University in the 1970s; the Image Processing Laboratory at UCLA in the 1980s-1990s; as well as the early PACS development at the Hokkaido University, Sapporo, Japan, in the late 1970s, and film scanner and digital radiography developed by Konishiroku Photo Ind. Co. Ltd

An evaluation of a charge-coupled device (CCD) image sensors for use in spacecraft-borne imaging systems was conducted. The study resulted in design recommendations for two sensors, an approximately 500 times 500 element imagingdevice and a 1 times 190 element linear imagingdevice with a 190 times 121 buffer store. Emphasis was placed on the higher resolution, area-imaging sensor. The objectives of the proposed sensors are listed, results of the experiments are analyzed, and estimates of the device performance are presented. A summary of the major technical recommendations is included.

Mobile phones' electromagnetic interference with medicaldevices is an important issue for the medical safety of patients who are using life-supporting medicaldevices. This review mainly focuses on mobile phones' interference with implanted medicaldevices and with medical equipment located in critical areas of hospitals. A close look at the findings reveals that mobile phones may adversely affect the functioning of medicaldevices, and the specific effect and the degree of interference depend on the applied technology and the separation distance. According to the studies' findings and the authors' recommendations, besides mitigating interference, using mobile phones at a reasonable distance from medicaldevices and developing technology standards can lead to their effective use in hospital communication systems. PMID:23559585

The Food and Drug Administration (FDA) is classifying the dental sonography device into class I, when it is used to monitor temporomandibular joint sounds, and into class II, when it is used to interpret temporomandibular joint sounds for the diagnosis of temporomandibular joint disorders and associated orofacial pain. FDA is classifying the jaw tracking device into class I, when it is used to monitor mandibular jaw positions relative to the maxilla, and into class II, when it is used to interpret mandibular jaw positions relative to the maxilla, for the diagnosis of temporomandibular joint disorders and associated orofacial pain. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the MedicalDevice Amendments of 1976 (the 1976 amendments), the Safe MedicalDevices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the MedicalDevice User Fee and Modernization Act of 2002 (MDUFMA). PMID:14651050

With rapid advances in meso-, micro- and nano-scale technology devices and electronics, a new generation of advanced medicaldevices is emerging, which promises medical treatment that is less invasive and more accurate, automated, and effective. We examined the technological and economic status of five categories of medicaldevices. A set of metrology needs is identified for each of these categories and suggestions are made to address them. PMID:27096115

With rapid advances in meso-, micro- and nano-scale technology devices and electronics, a new generation of advanced medicaldevices is emerging, which promises medical treatment that is less invasive and more accurate, automated, and effective. We examined the technological and economic status of five categories of medicaldevices. A set of metrology needs is identified for each of these categories and suggestions are made to address them. PMID:27096115

In the proposed study, a medicaldevice maintenance management system (MEDEMAS) is designed and implemented which provides a data pool of medicaldevices, the maintenance protocols and other required information for these devices. The system also contains complete repair and maintenance history of a specific device. MEDEMAS creates optimal maintenance schedule for devices and enables the service technician to carry out and report maintenance/repair processes via remote access. Thus predicted future failures are possible to prevent or minimize. Maintenance and repair is essential for patient safety and proper functioning of the medicaldevices, as it prevents performance decrease of the devices, deterioration of the equipment, and detrimental effects on the health of a patient, the user or other interacting people. The study aims to make the maintenance process more accurate, more efficient, faster and easier to manage and organize; and much less confusing. The accumulated history of medicaldevices and maintenance personnel helps efficient facility planning.

The design specifications and predicted performance characteristics of a Charge-Coupled Device Area Imager and a Charge-Coupled Device Linear Imager are presented. The Imagers recommended are intended for use in space-borne imaging systems and therefore would meet the requirements for the intended application. A unique overlapping metal electrode structure and a buried channel structure are described. Reasons for the particular imager designs are discussed.

Speckle noise is an inherent property of medical ultrasound imaging, and it generally tends to reduce the image resolution and contrast, thereby reducing the diagnostic value of this imaging modality. As a result, speckle noise reduction is an important prerequisite, whenever ultrasound imaging is used for tissue characterization. Among the many methods that have been proposed to perform this task, there exists a class of approaches that use a multiplicative model of speckled image formation and take advantage of the logarithmical transformation in order to convert multiplicative speckle noise into additive noise. The common assumption made in a dominant number of such studies is that the samples of the additive noise are mutually uncorrelated and obey a Gaussian distribution. The present study shows conceptually and experimentally that this assumption is oversimplified and unnatural. Moreover, it may lead to inadequate performance of the speckle reduction methods. The study introduces a simple preprocessing procedure, which modifies the acquired radio-frequency images (without affecting the anatomical information they contain), so that the noise in the log-transformation domain becomes very close in its behavior to a white Gaussian noise. As a result, the preprocessing allows filtering methods based on assuming the noise to be white and Gaussian, to perform in nearly optimal conditions. The study evaluates performances of three different, nonlinear filters—wavelet denoising, total variation filtering, and anisotropic diffusion—and demonstrates that, in all these cases, the proposed preprocessing significantly improves the quality of resultant images. Our numerical tests include a series of computer-simulated and in vivo experiments. PMID:16471433

Speckle noise is an inherent property of medical ultrasound imaging, and it generally tends to reduce the image resolution and contrast, thereby reducing the diagnostic value of this imaging modality. As a result, speckle noise reduction is an important prerequisite, whenever ultrasound imaging is used for tissue characterization. Among the many methods that have been proposed to perform this task, there exists a class of approaches that use a multiplicative model of speckled image formation and take advantage of the logarithmical transformation in order to convert multiplicative speckle noise into additive noise. The common assumption made in a dominant number of such studies is that the samples of the additive noise are mutually uncorrelated and obey a Gaussian distribution. The present study shows conceptually and experimentally that this assumption is oversimplified and unnatural. Moreover, it may lead to inadequate performance of the speckle reduction methods. The study introduces a simple preprocessing procedure, which modifies the acquired radio-frequency images (without affecting the anatomical information they contain), so that the noise in the log-transformation domain becomes very close in its behavior to a white Gaussian noise. As a result, the preprocessing allows filtering methods based on assuming the noise to be white and Gaussian, to perform in nearly optimal conditions. The study evaluates performances of three different, nonlinear filters--wavelet denoising, total variation filtering, and anisotropic diffusion--and demonstrates that, in all these cases, the proposed preprocessing significantly improves the quality of resultant images. Our numerical tests include a series of computer-simulated and in vivo experiments. PMID:16471433

Content-based image retrieval (CBIR) methods in medicalimage databases have been designed to support specific tasks, such as retrieval of medicalimages. These methods cannot be transferred to other medical applications since different imaging modalities require different types of processing. To enable content-based queries in diverse collections of medicalimages, the retrieval system must be familiar with the current Image class prior to the query processing. Further, almost all of them deal with the DICOM imaging format. In this paper a novel algorithm based on energy information obtained from wavelet transform for the classification of medicalimages according to their modalities is described. For this two types of wavelets have been used and have been shown that energy obtained in either case is quite distinct for each of the body part. This technique can be successfully applied to different image formats. The results are shown for JPEG imaging format.

The goal of this study was to develop a calibrated on-line technique to extract as much diagnostically-relevant information as possible from conventional video-format echograms. The final aim is to improve the diagnostic potentials of medical ultrasound. Video-output images were acquired by a frame grabber board incorporated in a multiprocessor workstation. Calibration images were obtained from a stable tissue-mimicking phantom with known acoustic characteristics. Using these images as reference, depth dependence of the gray level could fairly be corrected for the transducer performance characteristics, for the observer-dependent equipment settings and for attenuation in the examined tissues. Second-order statistical parameters still displayed some nonconsistent depth dependencies. The results obtained with two echoscanners for the same phantom were different; hence, an a posteriori normalization of clinical data with the phantom data is indicated. Prior to processing of clinical echograms,. the anatomical reflections and echoless voids were removed automatically. The final step in the preprocessing concerned the compensation of the overall attenuation in the tissue. A 'sliding window' processing was then applied to a region of interest (ROI) in the 'back-scan converted' images. A number of first and second order statistical texture parameters and acoustical parameters were estimated in each window and assigned to the central pixel. This procedure results in a set of new 'parametric' images of the ROI, which can be inserted in the original echogram (gray value, color) or presented as a color overlay. A clinical example is presented for illustrating the potentials of the developed technique. Depending on the choice of the parameters, four full resolution calibrated parametric images can be calculated and simultaneously displayed within 5 to 20 seconds. In conclusion, an on-line technique has been developed to estimate acoustic and texture parameters with a reduced

Objective To investigate the regulatory approval of new medicaldevices. Design Cross sectional study of new medicaldevices reported in the biomedical literature. Data sources PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medicaldevices. The search was carried out during this period to allow time for regulatory approval. Eligibility criteria for study selection Articles were included if they reported a clinical study of a new medicaldevice and there was no evidence of a previous clinical study in the literature. We defined a medicaldevice according to the US Food and Drug Administration as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.” Main outcome measures Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device. Results 5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medicaldevices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be “substantially equivalent” to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published. Conclusions We identified a multitude of new medicaldevices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study. PMID:27207165

Medicalimaging is becoming a vital component of war on cancer. Tremendous amounts of medicalimage data are captured and recorded in a digital format during cancer care and cancer research. Facing such an unprecedented volume of image data with heterogeneous image modalities, it is necessary to develop effective and efficient content-based medicalimage retrieval systems for cancer clinical practice and research. While substantial progress has been made in different areas of content-based image retrieval (CBIR) research, direct applications of existing CBIR techniques to the medicalimages produced unsatisfactory results, because of the unique characteristics of medicalimages. In this paper, we develop a new multimodal medicalimage retrieval approach based on the recent advances in the statistical graphic model and deep learning. Specifically, we first investigate a new extended probabilistic Latent Semantic Analysis model to integrate the visual and textual information from medicalimages to bridge the semantic gap. We then develop a new deep Boltzmann machine-based multimodal learning model to learn the joint density model from multimodal information in order to derive the missing modality. Experimental results with large volume of real-world medicalimages have shown that our new approach is a promising solution for the next-generation medicalimaging indexing and retrieval system. PMID:26309389

Medicalimaging is becoming a vital component of war on cancer. Tremendous amounts of medicalimage data are captured and recorded in a digital format during cancer care and cancer research. Facing such an unprecedented volume of image data with heterogeneous image modalities, it is necessary to develop effective and efficient content-based medicalimage retrieval systems for cancer clinical practice and research. While substantial progress has been made in different areas of content-based image retrieval (CBIR) research, direct applications of existing CBIR techniques to the medicalimages produced unsatisfactory results, because of the unique characteristics of medicalimages. In this paper, we develop a new multimodal medicalimage retrieval approach based on the recent advances in the statistical graphic model and deep learning. Specifically, we first investigate a new extended probabilistic Latent Semantic Analysis model to integrate the visual and textual information from medicalimages to bridge the semantic gap. We then develop a new deep Boltzmann machine-based multimodal learning model to learn the joint density model from multimodal information in order to derive the missing modality. Experimental results with large volume of real-world medicalimages have shown that our new approach is a promising solution for the next-generation medicalimaging indexing and retrieval system. PMID:26309389

...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Investigational Device Exemptions (IDEs) for Early Feasibility MedicalDevice Clinical Studies, Including Certain First in Human (FIH) Studies.'' Through the approaches announced in this guidance, FDA intends to facilitate early feasibility studies of medicaldevices, using appropriate risk......

... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the MedicalDevices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the Medical... a disability, please contact AnnMarie Williams, Conference Management Staff, at 301-796-5966...

This article presents a model for regulating cognitive enhancement devices (CEDs). Recently, it has become very easy for individuals to purchase devices which directly modulate brain function. For example, transcranial direct current stimulators are increasingly being produced and marketed online as devices for cognitive enhancement. Despite posing risks in a similar way to medicaldevices, devices that do not make any therapeutic claims do not have to meet anything more than basic product safety standards. We present the case for extending existing medicaldevice legislation to cover CEDs. Medicaldevices and CEDs operate by the same or similar mechanisms and pose the same or similar risks. This fact coupled with the arbitrariness of the line between treatment and enhancement count in favour of regulating these devices in the same way. In arguing for this regulatory model, the paper highlights potential challenges to its implementation, and suggests solutions. PMID:25243073

The paper presents an application related to collaborative medicine using a browser based medical visualization system with focus on the medicalimage colorization process and the underlying open source web development technologies involved. Browser based systems allow physicians to share medical data with their remotely located counterparts or medical students, assisting them during patient diagnosis, treatment monitoring, surgery planning or for educational purposes. This approach brings forth the advantage of ubiquity. The system can be accessed from a any device, in order to process the images, assuring the independence towards having a specific proprietary operating system. The current work starts with processing of DICOM (Digital Imaging and Communications in Medicine) files and ends with the rendering of the resulting bitmap images on a HTML5 (fifth revision of the HyperText Markup Language) canvas element. The application improves the image visualization emphasizing different tissue densities. PMID:25991287

Through a case study of a fictional company, this article provides a guide on how to implement CE-marking procedures, as detailed in the MedicalDevice Directive. The overlap in transitional periods between the MedicalDevice and Electromagnetic Compatibility Directives is discussed, together with issues such as selection of conformity assessment routes. PMID:10158130

Despite their sophistication and value, single-use medicaldevices have become commodity items in the developed world. Cheap raw materials along with large scale manufacturing and distribution processes have combined to make many medicaldevices more expensive to resterilize, package and restock than to simply discard. This practice is not sustainable or scalable on a global basis. As the petrochemicals that provide raw materials become more expensive and the global reach of these devices continues into rapidly developing economies, there is a need for device designs that take into account the total life-cycle of these products, minimize the amount of non-renewable materials consumed and consider alternative hybrid reusable / disposable approaches. In this paper, we describe a methodology to perform life cycle and functional analyses to create additional design requirements for medicaldevices. These types of sustainable approaches can move the medicaldevice industry even closer to the "triple bottom line"--people, planet, profit. PMID:19964137

This comprehensive publication covers all aspects of image formation in modern medicalimaging modalities, from radiography, fluoroscopy, and computed tomography, to magnetic resonance imaging and ultrasound. It addresses the techniques and instrumentation used in the rapidly changing field of medicalimaging. Now in its fourth edition, this text provides the reader with the tools necessary to be comfortable with the physical principles, equipment, and procedures used in diagnostic imaging, as well as appreciate the capabilities and limitations of the technologies.

At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medicaldevices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medicaldevices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medicaldevices has long been a difficult problem for the medical information system, because the data from medicaldevices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medicaldevice integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching

At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medicaldevices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medicaldevices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medicaldevices has long been a difficult problem for the medical information system, because the data from medicaldevices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medicaldevice integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching

This paper demonstrates the benefits of adopting model-based design techniques for engineering medicaldevice software. By using a patient-controlled analgesic (PCA) infusion pump as a candidate medicaldevice, the authors show how using models to capture design information allows for i) fast and efficient construction of executable device prototypes ii) creation of a standard, reusable baseline software architecture for a particular device family, iii) formal verification of the design against safety requirements, and iv) creation of a safety framework that reduces verification costs for future versions of the device software. 1. PMID:21142522

Obesity continues to be a growing epidemic worldwide. Although bariatric surgery remains the most effective and durable treatment of obesity and its comorbidities, there is a need for less invasive yet efficacious weight loss therapies. Currently the Food and Drug Administration has approved two endoscopically placed intragastric balloon devices and a surgically placed vagal blockade device. Another device that holds promise, particularly for the treatment of type 2 diabetes, is the endoscopically placed duodenojejunal bypass sleeve. This article reviews the indications and current data regarding results for these devices. PMID:27519137

Upon implantation or insertion into patient's body for exerting the intended purpose like salvage of normal functions of vital organs, the medicaldevices are unfortunately becoming the sites of competition between host cell integration and microbial adhesion. Moreover, since there is an increased use of implanted medicaldevices, the incidence of biofilm-and medicaldevices-related nosocomial infections is also increasing progressively. To control microbial colonization and subsequent biofilm formation of the medicaldevices, different approaches either to enhance the efficiency of certain antimicrobial agents or to disrupt the basic physiology of the pathogenic microorganisms including novel small molecules and antipathogenic drugs are being explored. In addition, the various lipid-and polymer-based drug delivery carriers are also investigated for applying antibiofilm coating of the medicaldevices especially over catheters. The main intention of this review is therefore to summarize the major and/breakthrough inventions disclosed in patent literature as well as in research papers related to microbial colonization of medicaldevices and novel preventive strategies. This review starts with an overview of the preventive strategies followed by a short description about the potential of different lipidic-and polymeric-drug delivery carriers in eradicating the biofilm-associated infections from the medicaldevices. PMID:20236065

Optical images have been used in several medical situations to improve diagnosis of lesions or to monitor treatments. However, most systems employ expensive scientific (CCD or CMOS) cameras and need computers to display and save the images, usually resulting in a high final cost for the system. Additionally, this sort of apparatus operation usually becomes more complex, requiring more and more specialized technical knowledge from the operator. Currently, the number of people using smartphone-like devices with built-in high quality cameras is increasing, which might allow using such devices as an efficient, lower cost, portable imaging system for medical applications. Thus, we aim to develop methods of adaptation of those devices to optical medicalimaging techniques, such as fluorescence. Particularly, smartphones covers were adapted to connect a smartphone-like device to widefield fluorescence imaging systems. These systems were used to detect lesions in different tissues, such as cervix and mouth/throat mucosa, and to monitor ALA-induced protoporphyrin-IX formation for photodynamic treatment of Cervical Intraepithelial Neoplasia. This approach may contribute significantly to low-cost, portable and simple clinical optical imaging collection.

In this paper, we present a wavelet-based medicalimage compression scheme so that images displayed on different devices are perceptually lossless. Since visual sensitivity of human varies with different subbands, we apply the perceptual lossless criteria to quantize the wavelet transform coefficients of each subband such that visual distortions are reduced to unnoticeable. Following this, we use a high compression ratio hierarchical tree to code these coefficients. Experimental results indicate that our perceptually lossless coder achieves a compression ratio 2-5 times higher than typical lossless compression schemes while producing perceptually identical image content on the target display device.

The medicaldevice industry, strongly dominated by medium-sized firms, has significant growth potential and a high number of job opportunities with 170,000 employees in more than 11,000 companies. Approximately one third of the business volume is achieved with innovative products that are less than three years old. The safety, quality and efficiency of the products is tested and approved by CE certification. Due to the heterogeneous field of devices, however, evidence requirements must be differentiated according to the type of device in question. Transparency is as important as the type of evidence, and industry is well aware of the significance of transparency for credibility in the market. Industry believes that all the stakeholders affected must collaborate to define the evidence requirements and decide which data are necessary to assess the benefits of a technology. Before a consistent level of transparency can be achieved, however, it is crucial to jointly develop a framework of requirements including invasiveness, risk potential, patient-relevant endpoints and intended use of the technology, as well as the data source. Transparency is a process that can only be achieved if all stakeholders cooperate successfully. Also, it is important to keep in mind that the development of study designs and reliable evidence needs time. In the interest of all patients it is essential to maintain an innovation-friendly climate in Germany. PMID:21530908

Medicaldevice design is a challenging process, often requiring collaboration between medical and engineering domain experts. This collaboration can be best institutionalized through systematic knowledge transfer between the two domains coupled with effective knowledge management throughout the design innovation process. Toward this goal, we present the development of a semantic framework for medicaldevice design that unifies a large medical ontology with detailed engineering functional models along with the repository of design innovation information contained in the US Patent Database. As part of our development, existing medical, engineering, and patent document ontologies were modified and interlinked to create a comprehensive medicaldevice innovation and design tool with appropriate properties and semantic relations to facilitate knowledge capture, enrich existing knowledge, and enable effective knowledge reuse for different scenarios. The result is a Concept Ideation Framework for MedicalDevice Design (CIFMeDD). Key features of the resulting framework include function-based searching and automated inter-domain reasoning to uniquely enable identification of functionally similar procedures, tools, and inventions from multiple domains based on simple semantic searches. The significance and usefulness of the resulting framework for aiding in conceptual design and innovation in the medical realm are explored via two case studies examining medicaldevice design problems. PMID:25956618

Medicaldevice labeling is any information associated with a device targeted to the patient or lay caregiver. It is intended to help assure that the device is used safely and effectively. Medicaldevice labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes. The European commission has discussed a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies, proof of conformity in connection with medicaldevices. Device labeling is exceedingly difficult for manufacturers for many reasons like regulations from government bodies to ensure compliance, increased competent authority surveillance, increased audits and language requirements. PMID:22247840

The Food and Drug Administration (FDA) is classifying the laser fluorescence caries detection device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the MedicalDevice Amendments of 1976 (the amendments), the Safe MedicalDevices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:11010622

The development of novel multimodality imaging agents and techniques represents the current frontier of research in the field of medicalimaging science. However, the combination of nuclear tomography with optical techniques has yet to be established. Here, we report the use of the inherent optical emissions from the decay of radiopharmaceuticals for Cerenkov luminescence imaging (CLI) of tumors in vivo and correlate the results with those obtained from concordant immuno-PET studies. Methods In vitro phantom studies were used to validate the visible light emission observed from a range of radionuclides including the positron emitters 18F, 64Cu, 89Zr, and 124I; β-emitter 131I; and α-particle emitter 225Ac for potential use in CLI. The novel radiolabeled monoclonal antibody 89Zr-desferrioxamine B-[DFO-J591 for immuno-PET of prostate-specific membrane antigen (PSMA) expression was used to coregister and correlate the CLI signal observed with the immuno-PET images and biodistribution studies. Results Phantom studies confirmed that Cerenkov radiation can be observed from a range of positron-,β-, and α-emitting radionuclides using standard optical imagingdevices. The change in light emission intensity versus time was concordant with radionuclide decay and was also found to correlate linearly with both the activity concentration and the measured PET signal (percentage injected dose per gram). In vivo studies conducted in male severe combined immune deficient mice bearing PSMA-positive, subcutaneous LNCaP tumors demonstrated that tumor-specific uptake of 89Zr-DFO-J591 could be visualized by both immuno-PET and CLI. Optical and immuno-PET signal intensities were found to increase over time from 24 to 96 h, and biodistribution studies were found to correlate well with both imaging modalities. Conclusion These studies represent the first, to our knowledge, quantitative assessment of CLI for measuring radiotracer uptake in vivo. Many radionuclides common to both nuclear

The paper provides an introduction to the regulatory landscape affecting a particular category of medical technology, namely standalone software-sometimes referred to as 'software as a medicaldevice'. To aid the reader's comprehension of an often complex area, six case studies are outlined and discussed before the paper continues to provide detail of how software with a medical purpose in its own right can potentially be classified as a medicaldevice. The reader is provided an appreciation of how to go about classifying such software and references to support the developer new to the field in locating detailed regulatory support documents and contact points for advice. PMID:26415828

There are special medical cases, where standard medicalimaging modalities are able to offer sufficient results, but not in the optimal way. It means, that desired results are produced with unnecessarily high expenses, with redundant informations or with needless demands on patient. This paper deals with one special case, where information useful for examination is the body surface only, inner sight into the body is needless. New specialized medicalimagingdevice is developed for this situation. In the Introduction section, analysis of presently used medicalimaging modalities is presented, which declares, that no available imagingdevice is best fitting for mentioned purposes. In the next section, development of the new specialized medicalimagingdevice is presented, and its principles and functions are described. Then, the parameters of new device are compared with present ones. It brings significant advantages comparing to present imaging systems. PMID:25694857

... rulemaking (REG-113770-10) (the proposed regulations) in the Federal Register (77 FR 6028). The IRS and the... ``Intended for Humans'' A number of commenters suggested that certain devices, such as sterilization...

The Food and Drug Administration (FDA) is classifying the nonimplanted, peripheral electrical continence device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the MedicalDevice Amendments of 1976, the Safe MedicalDevices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:11010624

A compact integral three-dimensional (3D) imagingdevice for capturing high resolution 3D images has been developed that positions the lens array and image sensor close together. Unlike the conventional scheme, where a camera lens is used to project the elemental images generated by the lens array onto the image sensor, the developed device combines the lens array and image sensor into one unit and makes no use of a camera lens. In order to capture high resolution 3D images, a high resolution imaging sensor and a lens array composed of many elemental lenses are required, and in an experimental setup, a CMOS image sensor circuit patterned with multiple exposures and a multiple lens array were used. Two types of optics were implemented for controlling the depth of 3D images. The first type was a convex lens that is suitable for compressing a relatively large object space, and the second was an afocal lens array that is suitable for capturing a relatively small object space without depth distortion. The objects captured with the imagingdevice and depth control optics were reconstructed as 3D images by using display equipment consisting of a liquid crystal panel and a lens array. The reconstructed images were found to have appropriate motion parallax.

This book is covered under the following topics: Digital image display I-V; Quality assurance I-V; Clinical image presentation I-V; Imaging systems; Image compression; Workstations; and Medical diagnostic imaging support system for military medicine and other federal agencies.

... For Consumers Consumer Updates MedicalDevices that Treat Obesity: What to Know Share Tweet Linkedin Pin it ... be less invasive.” back to top How is obesity measured? Obesity is typically measured by calculating body ...

A scaling device projects a known optical pattern into the field of view of a camera, which can be employed as a reference scale in a resulting photograph of a remote object, for example. The device comprises an optical beam projector that projects two or more spaced, parallel optical beams onto a surface of a remotely located object to be photographed. The resulting beam spots or lines on the object are spaced from one another by a known, predetermined distance. As a result, the size of other objects or features in the photograph can be determined through comparison of their size to the known distance between the beam spots. Preferably, the device is a small, battery-powered device that can be attached to a camera and employs one or more laser light sources and associated optics to generate the parallel light beams. In a first embodiment of the invention, a single laser light source is employed, but multiple parallel beams are generated thereby through use of beam splitting optics. In another embodiment, multiple individual laser light sources are employed that are mounted in the device parallel to one another to generate the multiple parallel beams.

The Food and Drug Administration (FDA) is announcing that the tentative final rule on medicaldevice distributor reporting that appeared in the Federal Register of November 26, 1991 (56 FR 60024), is now a final rule by operation of law. This final rule requires distributors to submit reports to FDA and to manufacturers, of deaths, serious illnesses, and serious injuries related to medicaldevices and to submit reports to manufacturers of certain malfunctions that may cause a death, serious illness, or serious injury, if the malfunction were to recur. The final rule also changes the reporting standard for certain distributors that are importers, and changes the definition of the term "serious injury" to conform to a recent statutory amendment. In issuing this final rule, FDA is announcing that the tentative final rule relating to adverse event reporting requirements for distributors, including importers, has the status of a final rule, as of May 28, 1992, by operation of law under the Safe MedicalDevices Act of 1990 (the SMDA), as amended by the MedicalDevice Amendments of 1992 (the 1992 amendments), and is setting forth the regulations reflecting those requirements. FDA is also amending the regulations, based on consideration of comments on the November 26, 1991, tentative final rule, to require distributors to register their facilities and to list their devices with FDA. PMID:10128335

Technology and medical equipment devices have become integrated in the delivery of health care. These technologies and devices can introduce new risks, either through user error or malfunction. When these incidents occur, it is important they are reported so that learning and improvements are possible. A just culture encourages reporting of incidents by not blaming individuals, but rather by seeking to understand incidents in relation to how they occurred because of the systems in place. These concepts are explored through a case study in a dialysis unit where a malfunction of a medical equipment device (central venous catheter) was identified. The process for addressing the issue is defined and includes reviewing applicable data, reporting incidents, and evaluating devices that malfunctioned. Finally, the role of the frontline health care professional is identified as an important stakeholder in identifying issues with technology and medicaldevices, reporting these incidents, and participating in the process that resolves the issues. PMID:26901981

Medicaldevices are characterized notably by a wide heterogeneity (from tongue depressors to hip prostheses, and from non-implantable to invasive devices), a short life cycle with recurrent incremental innovations (from 18 months to 5 years), and an operator-dependent nature. The objective of the current round table was to develop proposals and recommendations concerning the prerequisites needed in order to meet the French health authorities expectations concerning requests for post-approval studies for medicaldevices, required in cases where short and long-term consequences are unknown. These studies, which are the responsibility of the manufacturer or the distributor of the medicaldevice, are designed to confirm the role of the medicaldevice in the therapeutic management strategy in a real-life setting. There are currently approximately 150 post-approval studies underway, mainly concerning class III devices, and the majority face difficulties implementing the study or meeting the study objectives. In light of this, the round table endeavored to clearly identify the conditions for implementation of post-approval studies specific to the characteristics of medicaldevices. Various areas of progress have been envisaged to improve the performance of these studies, and by consequence, the efficiency of reimbursement of medicaldevices by the national health insurance. These include providing manufacturers with the opportunity to better anticipate post-approval requirements, defining a study-specific primary objective, integrating a phase allowing dialogue between the manufacturer, the health authorities and the scientific committee, and increasing awareness and training of health professionals on the impact of post-approval clinical studies in terms of the reimbursement of medicaldevices by the national insurance. PMID:25230354

The fields of medicalimaging and medicalimaging instrumentation are increasingly important. The state-of-the-art continues to advance at a very rapid pace. In fact, various medicalimaging modalities are under development at the National Synchrotron Light Source (such as MECT and Transvenous Angiography.) It is important to understand how these techniques compare with today's more conventional imaging modalities. The purpose of this report is to provide some basic information about the various medicalimaging technologies currently in use and their potential developments as a basis for this comparison. This report is by no means an in-depth study of the physics and instrumentation of the various imaging modalities; instead, it is an attempt to provide an explanation of the physical bases of these techniques and their principal clinical and research capabilities.

The fields of medicalimaging and medicalimaging instrumentation are increasingly important. The state-of-the-art continues to advance at a very rapid pace. In fact, various medicalimaging modalities are under development at the National Synchrotron Light Source (such as MECT and Transvenous Angiography.) It is important to understand how these techniques compare with today`s more conventional imaging modalities. The purpose of this report is to provide some basic information about the various medicalimaging technologies currently in use and their potential developments as a basis for this comparison. This report is by no means an in-depth study of the physics and instrumentation of the various imaging modalities; instead, it is an attempt to provide an explanation of the physical bases of these techniques and their principal clinical and research capabilities.

From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medicaldevice development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medicaldevices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medicaldevices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medicaldevices will be presented from the viewpoint of an engineering mind. PMID:24143287

From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medicaldevice development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medicaldevices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medicaldevices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medicaldevices will be presented from the viewpoint of an engineering mind. PMID:24143287

... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Microbiology Devices Panel of the MedicalDevices Advisory...). The meeting will be open to the public. Name of Committee: Microbiology Devices Panel of the...

... Obstetrics and Gynecology Devices Panel of the MedicalDevices Advisory Committee. This meeting was announced in the Federal Register of July 14, 2011 (76 FR 41507). The amendment is being made to reflect a... HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the...

... Orthopaedic and Rehabilitation Devices Panel of the MedicalDevices Advisory Committee scheduled for April 5, 2013. The meeting was announced in the Federal Register of November 29, 2012 (77 FR 71195). The meeting... Devices Advisory Committee: Notice of Postponement of Meeting AGENCY: Food and Drug Administration,...

... in the Federal Register of August 9, 2011 (76 FR 48871). The meeting is postponed so that FDA can... HUMAN SERVICES Food and Drug Administration Immunology Devices Panel of the MedicalDevices Advisory.... SUMMARY: The Food and Drug Administration (FDA) is postponing the meeting of the Immunology Devices...

... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Immunology Devices Panel of the MedicalDevices Advisory...). The meeting will be open to the public. Name of Committee: Immunology Devices Panel of the...

... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the MedicalDevices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... sponsored by AtriCure, Inc., for the AtriCure Synergy Ablation System to be used for the treatment of...

... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the MedicalDevices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel...

... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the MedicalDevices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... approval application for the MitraClip Delivery System sponsored by Abbott Vascular. The system consists...

The Medical Information Bus (MIB) reference model defines a new, object-oriented MedicalDevice Data Language (MDDL), under development by the Institute of Electrical and Electronic Engineers Society (IEEE) P1073 MIB Standard Committee. The MDDL treats medicaldevices, host computers, humans and device parameters as objects, and provides a flexible and extensible language for describing and passing messages between objects. This paper describes the MDDL semantic reference model and presents an overview of the MDDL structure, within the framework of the International Standards Organization (ISO) System Management Overview (SMO) model. A simple example of how the MDDL can be used to construct a device event report is also described. PMID:10114051

Disclosed is an image display device in a digital TV that is capable of carrying out the conversion into various kinds of resolution by using single bit map data in the digital TV. The image display device includes: a data processing part for executing bit map conversion, compression, restoration and format-conversion for text data; a memory for storing the bit map data obtained according to the bit map conversion and compression in the data processing part and image data inputted from an arbitrary receiving part, the receiving part receiving one of digital image data and analog image data; an image outputting part for reading the image data from the memory; and a display processing part for mixing the image data read from the image outputting part and the bit map data converted in format from the a data processing part. Therefore, the image display device according to the present invention can convert text data in such a manner as to correspond with various resolution, carry out the compression for bit map data, thereby reducing the memory space, and support text data of an HTML format, thereby providing the image with the text data of various shapes.

Medicalimaging is an invaluable tool for diagnosis, surgical guidance, and assessment of treatment efficacy. The Network for Translational Research (NTR) for Optical Imaging consists of four research groups working to “bridge the gap” between lab discovery and clinical use of fluorescence- and photoacoustic-based imagingdevices used with imaging biomarkers. While the groups are using different modalities, all the groups face similar challenges when attempting to validate these systems for FDA approval and, ultimately, clinical use. Validation steps taken, as well as future needs, are described here. The group hopes to provide translational validation guidance for itself, as well as other researchers. PMID:22574264

This chapter details the necessity for alternative access concepts to the currently mainly text-based methods in medical information retrieval. This need is partly due to the large amount of visual data produced, the increasing variety of medicalimaging data and changing user patterns. The stored visual data contain large amounts of unused information that, if well exploited, can help diagnosis, teaching and research. The chapter briefly reviews the history of image retrieval and its general methods before technologies that have been developed in the medical domain are focussed. We also discuss evaluation of medical content-based image retrieval (CBIR) systems and conclude with pointing out their strengths, gaps, and further developments. As examples, the MedGIFT project and the Image Retrieval in Medical Applications (IRMA) framework are presented.

Medicalimages are acquired or stored digitally. These images can be very large in size and number, and compression can increase the speed of transmission and reduce the cost of storage. In the paper analysis of medicalimages' approximation using the transform method based on wavelet functions is investigated. The tested clinical images are taken from multiple anatomical regions and modalities (Computer Tomography CT, Magnetic Resonance MR, Ultrasound, Mammography and X-Ray images). To compress medicalimages, the threshold criterion has been applied. The mean square error (MSE) is used as a measure of approximation quality. Plots of the MSE versus compression percentage and approximated images are included for comparison of approximation efficiency.

We propose a method for medicalimage denoising using calculus of variations and local variance estimation by shaped windows. This method reduces any additive noise and preserves small patterns and edges of images. A pyramid structure-texture decomposition of images is used to separate noise and texture components based on local variance measures. The experimental results show that the proposed method has visual improvement as well as a better SNR, RMSE and PSNR than common medicalimage denoising methods. Experimental results in denoising a sample Magnetic Resonance image show that SNR, PSNR and RMSE have been improved by 19, 9 and 21 percents respectively. PMID:22606674

Given that neural networks have been widely reported in the research community of medicalimaging, we provide a focused literature survey on recent neural network developments in computer-aided diagnosis, medicalimage segmentation and edge detection towards visual content analysis, and medicalimage registration for its pre-processing and post-processing, with the aims of increasing awareness of how neural networks can be applied to these areas and to provide a foundation for further research and practical development. Representative techniques and algorithms are explained in detail to provide inspiring examples illustrating: (i) how a known neural network with fixed structure and training procedure could be applied to resolve a medicalimaging problem; (ii) how medicalimages could be analysed, processed, and characterised by neural networks; and (iii) how neural networks could be expanded further to resolve problems relevant to medicalimaging. In the concluding section, a highlight of comparisons among many neural network applications is included to provide a global view on computational intelligence with neural networks in medicalimaging. PMID:20713305

Medical film digitizers play an important transitory role as digital-to-analogue bridges in radiology. Their use requires performance evaluation to assure medicalimage quality. A complete quality control protocol is presented, based on a set of test objects adaptable to the specification of various digitizers. The protocol includes parameters such as uniformity, input-output response, noise, geometric distortion, spatial resolution, low contrast discrimination, film slippage and light leakage, as well as associated measurement methods. The applicability of the protocol is demonstrated with two types of medical film digitizers; a charge-coupled device (CCD) digitizer and a laser digitizer. The potential value of the protocol is also discussed. PMID:11560833

The medical sector, similarly to other industries such as the aviation industry, has to comply with multiple regulations, guidelines and standards. In addition, there are multiple definitions for the expression 'medicaldevice', and before entering the market, manufacturers must demonstrate their product's safety and effectiveness. In such a complex and demanding environment, it is crucial to know the particularities surrounding the product being developed in order to minimize the chances of a commercial flop. Thus, in this paper, medicaldevice specificities are identified, and the most relevant legislation is reviewed providing the foundations for a dedicated product development methodology. PMID:22702261

OBJECTIVES: The US Food and Drug Administration industry guidelines for manufacturers of oral, over-the-counter, liquid medications recommend that these products be packaged with dosage-delivery devices. This study describes the prevalence of these devices and instructions packaged with prescription, oral, liquid medications. METHODS: This was a descriptive study of prescription oral-liquid medications dispensed during a 6-month period at a community pharmacy. Product information was obtained from the National Library of Medicine's DailyMed database and from the products themselves. Endpoints included provision of a measuring device, the type of device, the maximum dose measurable and intervals on the provided device, and inclusion of instructions to the pharmacist. RESULTS: A total of 382 liquid prescription medications were included in the study. Forty-nine of the 382 products (12.8%) were packaged with a measuring device. The most commonly provided device was a calibrated dropper (n = 18; 36.7%), followed by an oral syringe with a bottle adaptor (n = 9, 18.4%). Specific instructions on proper use of the provided measuring device were included with 20 products (40.8%). Among the products that did not provide a measuring device, only 70 of the 333 package inserts (21%) included instructions to the pharmacist regarding counseling the patient on proper administration. CONCLUSIONS: Packaging of prescription oral-liquid medications is inconsistent and leaves room for vast variability in patient or parent administration practices. In the future, patterns of actual dispensing practices among pharmacies and pharmacists would help determine the true incidence of dispensing of measuring devices. PMID:26997931

The market of medicaldevices is growing continuously worldwide. With the DLP™ technology from Texas Instruments Lüllau Engineering GmbH in Germany has realized different applications in the medical discipline of dermatology. Especially a new digital phototherapy device named skintrek™ PT5 is revolutionizing the treatment of skin diseases like psoriasis , Vitiligo and other Eczema. The functions of the new phototherapy device can only be realized through DLP™ technology which is not only be used for the selective irradiation process. In combination with other optical systems DLP™ technology undertakes also other functionalities like 3D-topology calculation und patient movement compensation.

The image of an 80 to 90 percent underexposed medical radiograph can be increased to readable density and contrast by autoradiographic image intensification. The technique consists of combining the image silver of the radiograph with a radioactive compound, thiourea labeled with sulfur-35, and then making an autoradiograph from the activated negative.

Financial pressures, an aging population, and a rising number of patients with chronic diseases, have encouraged the use of remote monitoring technologies. This usually entails at least one physiological parameter measurement for a clinician. Mobile telecommunication technologies lend themselves to this functionality, and in some cases, avoid some of the issues encountered with device integration. Moreover, the inherent characteristics of the mobile telecommunications infrastructure allow a coupling of business and clinical functions that were not possible before. Table I compares and contrasts some key aspect of device integration in and out of a healthcare facility. An HTM professional may be part of the team that acquires and/or manages a system using a mobile telecommunications technology. It is important for HTM professionals to ensure the data is in a standard format so that the interfaces across this system don't become brittle and break easily if one part changes. Moreover, the security and safety considerations of the system and the data should be a primary consideration in and y purchase, with attention given to the proper environmental and encryption mechanisms. Clinical engineers and other HTM professionals are unique in that they understand the patient/clinician/device interface and the need to ensure its safety and effectiveness regardless of geographical environment. PMID:23692108

Rules on the reprocessing of medicaldevices were put into place in Germany in 2001. The present article explains the background situation and the provisions that are currently in force. The implementation of these statutory requirements is described using the example of the quality management system of Germany’s market leader, Vanguard AG. This quality management system was successfully certified pursuant to DIN EN ISO 13485:2003 for the scope "reprocessing of medicaldevices", including class “critical C”, in accordance with the recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert-Koch-Institute (RKI) and the German Federal Institute for Drugs and MedicalDevices (BfArM) on the “Hygiene requirements for reprocessing of medical devices”. PMID:20204094

Over the last few years, an increasing number of lawsuits have been filed involving inferior vena cava filters. This has prompted the U.S. Judicial Panel on Multidistrict Litigation to centralize these lawsuits into two multidistrict litigations: one for Cook's filters and one for Bard's. Both sets of cases share similar questions of facts, in particular whether these filters' design and manufacturing practices made them unreasonably prone to serious complications. The resolution of these cases will add to a larger legal debate concerning how much legal protection the 1976 MedicalDevice Amendments should offer firms from tort liability. As a specialty that often relies on medicaldevices, it is not only important for interventional radiologists to have a general understanding of medicaldevice litigation but also to reflect upon the approaches to informed consent regarding these devices. PMID:27247482

The Food and Drug Administration (FDA) is classifying the endotoxin assay into class II (special controls). The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the MedicalDevice Amendments of 1976 (the amendments), the Safe MedicalDevices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the MedicalDevice User Fee and Modernization Act of 2002 (MDUFMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device. PMID:14594019

This paper presents laser-induced fluroescence method (LIF) employing endogenous ("autofluroescence") and exogenous fluorophores. LIF is applied for clinical diagnosis in dermatology, gynaecology, urology, lung tumors as well as for early dentin caries. We describe the analysers with He-Ne, He-Cd, and SHG Nd:YAG lasers and new generation systems based on blue semiconductor GaN lasers that have been implemented into clinical practice till now. The LIF method, fundamental one for many medical applications, with excitation radiation of wavelength 400 nm could be appl,ied only using tunable dye lasers or titanium lasers adequte for laboratory investigations. Development of GaN laser shows possibility to design portable, compact diagnostic devices as multi-channel analysers of fluorescence spectra and surface imaging devoted to clinical application. The designed systems used for spectra measurement and registration of fluorescence images include lasers of power 5-30 mW and generate wavelengths of 405-407 nm. They are widely used in PDT method for investigation of superficial distribution of accumulation kinetics of all known photosensitizers, their elimination, and degradation as well as for treatment of superficial lesions of mucosa and skin. Excitation of exogenous porphrins in Soret band makes possible to estimate their concentration and a period of healthy skin photosensitivity that occurs after photosensitiser injections. Due to high sensitivity of spectrum analysers, properties of photosensitisers can be investigated in vitro (e.g. their aggregation, purity, chromatographic distributions) when their concentrations are 2-3 times lower in comparison to concentrations investigated with typical spectrofluorescence methods. Dentistry diagnosis is a new field in which GaN laser devices can be applied. After induction with blue light, decreased autofluorescence intensity can be observed when dentin caries occur and strong characteristic bands of endogenous porphyrines

New technologies introduced over the past three decades have transformed medical diagnosis and treatment, and significantly improved patient outcomes. These changes have been mediated by the introduction of new medicaldevices, particularly for the treatment of cardiovascular, orthopedic, and ophthalmic disorders. These devices, in turn, have created large markets and spawned a burgeoning medicaldevice industry, including six Fortune 500 companies whose combined market capitalization now exceeds 400 billion dollars. This success story, which has unquestionably benefited patients and society alike, has been dependent upon an intense collaboration among industry, clinicians, and regulatory authorities. However, when physicians actively involved in patient care participate in such collaborations, they are increasingly vulnerable to creating potential conflicts between these two (clinical and device development) roles. Such conflicts, which may ultimately erode public trust, have important consequences not only for the individual physicians, but also for their parent institutions, their patients, sponsoring companies, and the entire clinical research enterprise that makes the development and introduction of new devices possible. The third Dartmouth Device Development Symposium held in October 2005 brought together thought leaders within the medicaldevice community, including academicians, clinical investigators, regulators from the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS), large and small device manufacturers and the financial (venture capital and investment banks) community. The Symposium examined the conflicts of interest encountered during the early development and commercialization of a medicaldevice. The goal of these discussions was to (1) identify and characterize the conflicts that arise and (2) provide strategies to address these conflicts. This manuscript was prepared by a writing committee to provide a summary

... September 30, 2008 (73 FR 58604, October 7, 2008); the comment period closed on January 5, 2009. FDA held.../biological products that provide image contrast enhancement. The final guidance announced in this document... developers of medicalimagingdevices and imaging drug/ biological products that provide image...

In this paper, a fast lossless compression scheme is presented for the medicalimage. This scheme consists of two stages. In the first stage, a Differential Pulse Code Modulation (DPCM) is used to decorrelate the raw image data, therefore increasing the compressibility of the medicalimage. In the second stage, an effective scheme based on the Huffman coding method is developed to encode the residual image. This newly proposed scheme could reduce the cost for the Huffman coding table while achieving high compression ratio. With this algorithm, a compression ratio higher than that of the lossless JPEG method for image can be obtained. At the same time, this method is quicker than the lossless JPEG2000. In other words, the newly proposed algorithm provides a good means for lossless medicalimage compression. PMID:17280962

The application of THz to medicalimaging is experiencing a surge in both interest and federal funding. A brief overview of the field is provided along with promising and emerging applications and ongoing research. THz imaging phenomenology is discussed and tradeoffs are identified. A THz medicalimaging system, operating at ~525 GHz center frequency with ~125 GHz of response normalized bandwidth is introduced and details regarding principles of operation are provided. Two promising medical applications of THz imaging are presented: skin burns and cornea. For burns, images of second degree, partial thickness burns were obtained in rat models in vivo over an 8 hour period. These images clearly show the formation and progression of edema in and around the burn wound area. For cornea, experimental data measuring the hydration of ex vivo porcine cornea under drying is presented demonstrating utility in ophthalmologic applications. PMID:26085958

A common thread in much of the medicalimaging that has developed over the past 20 years has been the Fourier transform. It was Richard Bates' interest in radio-interferometry, as well as his fascination with problems of medicalimaging that prompted an initial interest in applying Fourier techniques to medicalimaging in general and to Computed Tomography in particular. This resulted 20 years ago in one of the earliest technical papers advocating Fourier techniques for reconstructing cross-sections from radiographic projections (Bates and Peters, NZ J Science 14:883-896, 1971). Since those early days, medicalimaging has explored into a multi-billion dollar industry. The CT scanner has become the workhorse imaging modality in the radiology department, while its more recent relative, the MR scanner, is rapidly gaining ground as a technique of even greater importance. Richard Bates, with his team of "MedicalImagers" was a very significant force in the development of the field of MedicalImaging as we know it today. This paper attempts to chronicle the genesis of this process from the personal perspective of the author. PMID:1789769

Image registration of low contrast image sequences is provided. In one aspect, a desired region of an image is automatically segmented and only the desired region is registered. Active contours and adaptive thresholding of intensity or edge information may be used to segment the desired regions. A transform function is defined to register the segmented region, and sub-pixel information may be determined using one or more interpolation methods.

A true allergy to a medication is different than a simple adverse reaction to the drug. The allergic reaction occurs when the immune system, having been exposed to the drug before, creates antibodies to ...

As the number of consumer digital images escalates by tens of billions each year, an increasing proportion of these images are being acquired using the latest generations of sophisticated mobile devices. The characteristics of the cameras embedded in these devices now yield image-quality outcomes that approach those of the parallel generations of conventional digital cameras, and all aspects of the management and optimization of these vast new image-populations become of utmost importance in providing ultimate consumer satisfaction. However this satisfaction is still limited by the fact that a substantial proportion of all images are perceived to have inadequate image quality, and a lesser proportion of these to be completely unacceptable (for sharing, archiving, printing, etc). In past years at this same conference, the author has described various aspects of a consumer digital-image interface based entirely on an intuitive image-choice-only operation. Demonstrations have been given of this facility in operation, essentially allowing criticalpath navigation through approximately a million possible image-quality states within a matter of seconds. This was made possible by the definition of a set of orthogonal image vectors, and defining all excursions in terms of a fixed linear visual-pixel model, independent of the image attribute. During recent months this methodology has been extended to yield specific user-interactive image-quality solutions in the form of custom software, which at less than 100kb is readily embedded in the latest generations of unlocked portable devices. This has also necessitated the design of new user-interfaces and controls, as well as streamlined and more intuitive versions of the user quality-choice hierarchy. The technical challenges and details will be described for these modified versions of the enhancement methodology, and initial practical experience with typical images will be described.

We introduce a novel platform for medicaldevice training: hybrid physical-virtual simulators of medicaldevices, combining touchscreen-enabled virtual emulations of real devices with sensorized physical peripherals to enable tactile, hands-on interaction between the trainee, simulated device and standardized patients or mannequins. The system enables objective measurement and recording of trainee performance, including interactions with both the virtual device elements and the physical components, and can include metrics and feedback not available in the real device. The system also includes an integrated wireless signaling device for use with standardized patients. We present the implementation of an example system, a virtual defibrillator with sensorized paddles and wireless signaling of successful defibrillator operation. PMID:23400187

Methods developed by the clinical engineering community and the principles outlined by ISO regulations for the application of risk management to medicaldevices were integrated to provide a basis for the unique optimization system implemented into the University Health Network medicaldevice maintenance program. Device maintenance history data stored in the database is used to conduct a risk analysis and to compute predefined benchmarks to highlight groups of equipment for which the current maintenance regime is not optimal. Using a software data research tool we are able to investigate device history data and support alterations in maintenance intervals, user training, maintenance procedures, and/or device purchasing. These alterations are justified, documented, and monitored for risk in a continuous management cycle. The predicted benefits are an overall improvement in the reliability of the devices maintained, coupled with a drop in repetitive device checks that result in no measurable benefits. PMID:11765697

This paper presents a Web-based medicalimage archive system in three-tier, client-server architecture for the storage and retrieval of medicalimage data, as well as patient information and clinical data. The Web-based medicalimage archive system was designed to meet the need of the National Institute of Neurological Disorders and Stroke for a central image repository to address questions of stroke pathophysiology and imaging biomarkers in stroke clinical trials by analyzing images obtained from a large number of clinical trials conducted by government, academic and pharmaceutical industry researchers. In the database management-tier, we designed the image storage hierarchy to accommodate large binary image data files that the database software can access in parallel. In the middle-tier, a commercial Enterprise Java Bean server and secure Web server manages user access to the image database system. User-friendly Web-interfaces and applet tools are provided in the client-tier for easy access to the image archive system over the Internet. Benchmark test results show that our three-tier image archive system yields fast system response time for uploading, downloading, and querying the image database.

Medicalimages constitute a core portion of the information a physician utilizes to render diagnostic and treatment decisions. At a fundamental level, this diagnostic process involves two basic processes: visually inspecting the image (visual perception) and rendering an interpretation (cognition). The likelihood of error in the interpretation of medicalimages is, unfortunately, not negligible. Errors do occur, and patients’ lives are impacted, underscoring our need to understand how physicians interact with the information in an image during the interpretation process. With improved understanding, we can develop ways to further improve decision making and, thus, to improve patient care. The science of medicalimage perception is dedicated to understanding and improving the clinical interpretation process. PMID:20601701

Johnson Space Center, Henry Ford Hospital in Detroit, and Houston-based Wyle Laboratories collaborated on NASA's Advanced Diagnostic Ultrasound in Microgravity (ADUM) experiment, which developed revolutionary medical ultrasound diagnostic techniques for long-distance use. Mediphan, a Canadian company with U.S. operations in Springfield, New Jersey drew on NASA expertise to create frame-grabber and data archiving technology that enables ultrasound users with minimal training to send diagnostic-quality ultrasound images and video to medical professionals via the Internet in near real time allowing patients as varied as professional athletes, Olympians, and mountain climbers to receive medical attention as soon as it is needed.

A laser focus compensating sensing and imagingdevice permits the focus of a single focal point of different frequency laser beams emanating from the same source point. In particular it allows the focusing of laser beam originating from the same laser device but having differing intensities so that a low intensity beam will not convert to a higher frequency when passing through a conversion crystal associated with the laser generating device. The laser focus compensating sensing and imagingdevice uses a cassegrain system to fold the lower frequency, low intensity beam back upon itself so that it will focus at the same focal point as a high intensity beam. An angular tilt compensating lens is mounted about the secondary mirror of the cassegrain system to assist in alignment. In addition cameras or CCD's are mounted with the primary mirror to sense the focused image. A convex lens is positioned co-axial with the cassegrain system on the side of the primary mirror distal of the secondary for use in aligning a target with the laser beam. A first alternate embodiment includes a cassegrain system using a series of shutters and an internally mounted dichroic mirror. A second alternate embodiment uses two laser focus compensating sensing and imagingdevices for aligning a moving tool with a work piece.

A laser focus compensating sensing and imagingdevice permits the focus of a single focal point of different frequency laser beams emanating from the same source point. In particular it allows the focusing of laser beam originating from the same laser device but having differing intensities so that a low intensity beam will not convert to a higher frequency when passing through a conversion crystal associated with the laser generating device. The laser focus compensating sensing and imagingdevice uses a Cassegrain system to fold the lower frequency, low intensity beam back upon itself so that it will focus at the same focal point as a high intensity beam. An angular tilt compensating lens is mounted about the secondary mirror of the Cassegrain system to assist in alignment. In addition cameras or CCD's are mounted with the primary mirror to sense the focused image. A convex lens is positioned co-axial with the Cassegrain system on the side of the primary mirror distal of the secondary for use in aligning a target with the laser beam. A first alternate embodiment includes a Cassegrain system using a series of shutters and an internally mounted dichroic mirror. A second alternate embodiment uses two laser focus compensating sensing and imagingdevices for aligning a moving tool with a work piece.

The safety of any medicaldevice system is dependent on the application of a disciplined, well-defined, risk management process throughout the product life cycle. Hardware, software, human, and environmental interactions must be assessed in terms of intended use, risk, and cost/benefit criteria. This article addresses these issues in the context of medicaldevices that incorporate software. The article explains the principles of risk management, using terminology and examples from the domain of software engineering. It may serve as a guide to those new to the concepts of risk management and as an aide-memoire for medicaldevice system/software engineers who are more familiar with the topic. PMID:12162111

Data from connected medicaldevices (CMDS) provides an objective and rich source of information to augment patient care management and clinical decision making. A principal reason is measurements of patient properties made through bedside CMDs are not typically subject to errors associated with misinterpretation, incorrect recording, and incorrect time stamping. Furthermore, data from CMDs can be collected regularly, ensuring a dense and robust data record on a given patient. The ability to remotely manage and monitor patients is greatly facilitated by access to data, as measurements represent an objective source of information that facilitate clinical decision making. In my recent book, Connected MedicalDevices: Integrating Patient Care Data in Healthcare System, I discuss the topic of medicaldevice integration (MDI) in relation to implementing CMDs in healthcare settings as a guide to assist hospitals in this undertaking. The following discussion about MDI are the opening paragraphs from this text, followed by a discussion of MDI architectures. PMID:26571635

Medicalimaging used to be primarily within the domain of radiology, but with the advent of virtual pathology slides and telemedicine, imaging technology is expanding in the healthcare enterprise. As new imaging technologies are developed, they must be evaluated to assess the impact and benefit on patient care. The authors review the hierarchical model of the efficacy of diagnostic imaging systems by Fryback and Thornbury [Med. Decis. Making 11, 88-94 (1991)] as a guiding principle for system evaluation. Evaluation of medicalimaging systems encompasses everything from the hardware and software used to acquire, store, and transmit images to the presentation of images to the interpreting clinician. Evaluation of medicalimaging systems can take many forms, from the purely technical (e.g., patient dose measurement) to the increasingly complex (e.g., determining whether a new imaging method saves lives and benefits society). Evaluation methodologies cover a broad range, from receiver operating characteristic (ROC) techniques that measure diagnostic accuracy to timing studies that measure image-interpretation workflow efficiency. The authors review briefly the history of the development of evaluation methodologies and review ROC methodology as well as other types of evaluation methods. They discuss unique challenges in system evaluation that face the imaging community today and opportunities for future advances. PMID:18383686

Many widely used digital medicalimage collections have been established but these are generally used as raw data sources without related image analysis toolsets. Providing associated functionality to allow specific types of operations to be performed on these images has proved beneficial in some cases (e.g. brain image registration and atlases). However, toolset development to provide generic image analysis functions on medicalimages has tended to be ad hoc, with Open Source options proliferating (e.g. ITK). Our Automated MedicalImage Collection Annotation (AMICA) system is both an image repository, to which the research community can contribute image datasets, and a search/retrieval system that uses automated image annotation. AMICA was designed for the Windows Azure platform to leverage the flexibility and scalability of the cloud. It is intended that AMICA will expand beyond its initial pilot implementation (for brain CT, MR images) to accommodate a wide range of modalities and anatomical regions. This initiative aims to contribute to advances in clinical research by permitting a broader use and reuse of medicalimage data than is currently attainable. For example, cohort studies for cases with particular physiological or phenotypical profiles will be able to source and include enough cases to provide high statistical power, allowing more individualised risk factors to be assessed and thus allowing screening and staging processes to be optimised. Also, education, training and credentialing of clinicians in image interpretation, will be more effective because it will be possible to select instances of images with specific visual aspects, or correspond to types of cases where reading performance improvement is desirable.

Clinical translation of scientific discoveries is often the long-term goal of academic medical research. However, this goal is not always realized due to the complicated path between bench research and clinical use. In this review, we outline the fundamental steps required for first-in-human testing of a new imagingdevice, and use the FLARE™ (Fluorescence-Assisted Resection and Exploration) near-infrared fluorescence optical imaging platform as an example. PMID:19964033

Advances in wireless technologies, low-power electronics, the internet of things, and in the domain of connected health are driving innovations in wearable medicaldevices at a tremendous pace. Wearable sensor systems composed of flexible and stretchable materials have the potential to better interface to the human skin, whereas silicon-based electronics are extremely efficient in sensor data processing and transmission. Therefore, flexible and stretchable sensors combined with low-power silicon-based electronics are a viable and efficient approach for medical monitoring. Flexible medicaldevices designed for monitoring human vital signs, such as body temperature, heart rate, respiration rate, blood pressure, pulse oxygenation, and blood glucose have applications in both fitness monitoring and medical diagnostics. As a review of the latest development in flexible and wearable human vitals sensors, the essential components required for vitals sensors are outlined and discussed here, including the reported sensor systems, sensing mechanisms, sensor fabrication, power, and data processing requirements. PMID:26867696

Medicaldevices designed to network can share data with a Clinical Information System (CIS), making that data available within clinician workflow. Some lessons learned by transitioning anesthesia reporting and monitoring devices (ARMDs) on a local area network (LAN) to integration of anesthesia documentation within a CIS include the following categories: access, contracting, deployment, implementation, planning, security, support, training and workflow integration. Areas identified for improvement include: Vendor requirements for access reconciled with the organizations' security policies and procedures. Include clauses supporting transition from stand-alone devices to information integrated into clinical workflow in the medicaldevice procurement contract. Resolve deployment and implementation barriers that make the process less efficient and more costly. Include effective field communication and creative alternatives in planning. Build training on the baseline knowledge of trainees. Include effective help desk processes and metrics. Have a process for determining where problems originate when systems share information. PMID:24199054

Medical procedures often involve the use of the tactile sense to manipulate organs or tissues by using special tools. Doctors require extensive preparation in order to perform them successfully; for example, research shows that a minimum of 750 operations are needed to acquire sufficient experience to perform medical procedures correctly. Haptic devices have become an important training alternative and they have been considered to improve medical training because they let users interact with virtual environments by adding the sense of touch to the simulation. Previous articles in the field state that haptic devices enhance the learning of surgeons compared to current training environments used in medical schools (corpses, animals, or synthetic skin and organs). Consequently, virtual environments use haptic devices to improve realism. The goal of this paper is to provide a state of the art review of recent medical simulators that use haptic devices. In particular we focus on stitching, palpation, dental procedures, endoscopy, laparoscopy, and orthopaedics. These simulators are reviewed and compared from the viewpoint of used technology, the number of degrees of freedom, degrees of force feedback, perceived realism, immersion, and feedback provided to the user. In the conclusion, several observations per area and suggestions for future work are provided. PMID:26888655

The Food and Drug Administration (FDA) is classifying the breast lesion documentation system into class II (special controls). The special controls that will apply to this device are discussed later in this document. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the MedicalDevice Amendments of 1976 (the amendments), the Safe MedicalDevices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device. PMID:12884877

Many people in developing countries cannot afford or rely on certain modes of electricity. We establish the reasonability of relying on lead-acid batteries, 9 V alkaline batteries, and lithium-ion batteries for charging low-voltage medical equipment. Based on the research and tests we conducted, we determined that using these battery types to charge medicaldevices truly is a reasonable solution. PMID:19964250

With increasing knowledge of the materials science of bulk metallic glasses (BMGs) and improvements in their properties and processing, they have started to become candidate materials for biomedical devices. A dichotomy in the types of medical applications has also emerged, in which some families of BMGs are being developed for permanent devices whilst another family - of Mg-based alloys - is showing promise in bioabsorbable implants. The current status of these metallurgical and technological developments is summarized. PMID:27031058

The aim of this paper is to present current controversies concerning the safety of medicaldevices and procedures under pressure in a hyperbaric chamber including: defibrillation in a multiplace chamber; implantable devices during hyperbaric oxygen treatment (HBOT) and the results of a recent European questionnaire on medicaldevices used inside hyperbaric chambers. Early electrical defibrillation is the only effective therapy for cardiac arrest caused by ventricular fibrillation or pulseless ventricular tachycardia. The procedure of defibrillation under hyperbaric conditions is inherently dangerous owing to the risk of fire, but it can be conducted safely if certain precautions are taken. Recently, new defibrillators have been introduced for hyperbaric medicine, which makes the procedure easier technically, but it must be noted that sparks and fire have been observed during defibrillation, even under normobaric conditions. Therefore, delivery of defibrillation shock in a hyperbaric environment must still be perceived as a hazardous procedure. Implantable devices are being seen with increasing frequency in patients referred for HBOT. These devices create a risk of malfunction when exposed to hyperbaric conditions. Some manufacturers support patients and medical practitioners with information on how their devices behave under increased pressure, but in some cases an individual risk-benefit analysis should be conducted on the patient and the specific implanted device, taking into consideration the patient's clinical condition, the indication for HBOT and the capability of the HBOT facility for monitoring and intervention in the chamber. The results of the recent survey on use of medicaldevices inside European hyperbaric chambers are also presented. A wide range of non-CE-certified equipment is used in European chambers. PMID:25596835

series of dynamic protocols to isolate and assess balance function deficiencies. The technology was based on Nashner s novel, engineering-inspired concept of balance as an adaptable collaboration between multiple sensory and motor systems. CDP proved useful not only for examining astronauts, but for anyone suffering from balance problems. Today, CDP is the standard medical tool for objectively evaluating balance control.

A medicalimaging system provides simultaneous rendering of visible light and fluorescent images. The system may employ dyes in a small-molecule form that remain in a subject's blood stream for several minutes, allowing real-time imaging of the subject's circulatory system superimposed upon a conventional, visible light image of the subject. The system may provide an excitation light source to excite the fluorescent substance and a visible light source for general illumination within the same optical guide used to capture images. The system may be configured for use in open surgical procedures by providing an operating area that is closed to ambient light. The systems described herein provide two or more diagnostic imaging channels for capture of multiple, concurrent diagnostic images and may be used where a visible light image may be usefully supplemented by two or more images that are independently marked for functional interest.

A medicalimaging system provides simultaneous rendering of visible light and fluorescent images. The system may employ dyes in a small-molecule form that remain in the subject's blood stream for several minutes, allowing real-time imaging of the subject's circulatory system superimposed upon a conventional, visible light image of the subject. The system may provide an excitation light source to excite the fluorescent substance and a visible light source for general illumination within the same optical guide used to capture images. The system may be configured for use in open surgical procedures by providing an operating area that is closed to ambient light. The systems described herein provide two or more diagnostic imaging channels for capture of multiple, concurrent diagnostic images and may be used where a visible light image may be usefully supplemented by two or more images that are independently marked for functional interest.

Up until about two decades ago acoustic imaging and ultrasound imaging were synonymous. The term “ultrasonography,” or its abbreviated version “sonography” meant an imaging modality based on the use of ultrasonic compressional bulk waves. Since the 1990s numerous acoustic imaging modalities started to emerge based on the use of a different mode of acoustic wave: shear waves. It was demonstrated that imaging with these waves can provide very useful and very different information about the biological tissue being examined. We will discuss physical basis for the differences between these two basic modes of acoustic waves used in medicalimaging and analyze the advantages associated with shear acoustic imaging. A comprehensive analysis of the range of acoustic wavelengths, velocities, and frequencies that have been used in different imaging applications will be presented. We will discuss the potential for future shear wave imaging applications. PMID:23643056

Medicalimaging has become an absolutely essential diagnostic tool for clinical practices; at present, pathologies can be detected with an earliness never before known. Its use has not only been relegated to the field of radiology but also, increasingly, to computer-based imaging processes prior to surgery. Motion analysis, in particular, plays an important role in analyzing activities or behaviors of live objects in medicine. This short paper presents several low-cost hardware implementation approaches for the new generation of tablets and/or smartphones for estimating motion compensation and segmentation in medicalimages. These systems have been optimized for breast cancer diagnosis using magnetic resonance imaging technology with several advantages over traditional X-ray mammography, for example, obtaining patient information during a short period. This paper also addresses the challenge of offering a medical tool that runs on widespread portable devices, both on tablets and/or smartphones to aid in patient diagnostics. PMID:24489600

Even before the discovery of X-rays, attempts at non-invasive medicalimaging required an understanding of fundamental principles of physics. Students frequently do not see these connections because they are not taught in beginning physics courses. To help students understand that physics and medicalimaging are closely connected, we have developed a series of active learning units. For each unit we begin by studying how students transfer their knowledge from traditional physics classes and everyday experiences to medical applications. Then, we build instructional materials to take advantage of the students' ability to use their existing learning and knowledge resources. Each of the learning units involves a combination of hands-on activities, which present analogies, and interactive computer simulations. Our learning units introduce students to the contemporary imaging techniques of CT scans, magnetic resonance imaging (MRI), positron emission tomography (PET), and wavefront aberrometry. The project's web site is http://web.phys.ksu.edu/mmmm/.

Genetic algorithms (GAs) have been found to be effective in the domain of medicalimage segmentation, since the problem can often be mapped to one of search in a complex and multimodal landscape. The challenges in medicalimage segmentation arise due to poor image contrast and artifacts that result in missing or diffuse organ/tissue boundaries. The resulting search space is therefore often noisy with a multitude of local optima. Not only does the genetic algorithmic framework prove to be effective in coming out of local optima, it also brings considerable flexibility into the segmentation procedure. In this paper, an attempt has been made to review the major applications of GAs to the domain of medicalimage segmentation. PMID:19272859

Because continuous-energy Monte Carlo radiation transport calculations can be nearly exact simulations of physical reality (within data limitations, geometric approximations, transport algorithms, etc.), it follows that one should be able to closely approximate the results of many experiments from first-principles computations. This line of reasoning has led to various MCNP studies that involve simulations of medicalimaging modalities and other visualization methods such as radiography, Anger camera, computerized tomography (CT) scans, and SABRINA particle track visualization. It is the intent of this paper to summarize some of these imaging simulations in the hope of stimulating further work, especially as computer power increases. Improved interpretation and prediction of medicalimages should ultimately lead to enhanced medical treatments. It is also reasonable to assume that such computations could be used to design new or more effective imaging instruments.

Variable shadow screens have been proposed for reducing the apparent brightnesses of very bright light sources relative to other sources within the fields of view of diverse imaging optical devices, including video and film cameras and optical devices for imaging directly into the human eye. In other words, variable shadow screens would increase the effective dynamic ranges of such devices. Traditionally, imaging sensors are protected against excessive brightness by use of dark filters and/or reduction of iris diameters. These traditional means do not increase dynamic range; they reduce the ability to view or image dimmer features of an image because they reduce the brightness of all parts of an image by the same factor. On the other hand, a variable shadow screen would darken only the excessively bright parts of an image. For example, dim objects in a field of view that included the setting Sun or bright headlights could be seen more readily in a picture taken through a variable shadow screen than in a picture of the same scene taken through a dark filter or a narrowed iris. The figure depicts one of many potential variations of the basic concept of the variable shadow screen. The shadow screen would be a normally transparent liquid-crystal matrix placed in front of a focal-plane array of photodetectors in a charge-coupled-device video camera. The shadow screen would be placed far enough from the focal plane so as not to disrupt the focal-plane image to an unacceptable degree, yet close enough so that the out-of-focus shadows cast by the screen would still be effective in darkening the brightest parts of the image. The image detected by the photodetector array itself would be used as feedback to drive the variable shadow screen: The video output of the camera would be processed by suitable analog and/or digital electronic circuitry to generate a negative partial version of the image to be impressed on the shadow screen. The parts of the shadow screen in front of

With the widespread dissemination of picture archiving and communication systems (PACSs) in hospitals, the amount of imaging data is rapidly increasing. Effective image retrieval systems are required to manage these complex and large image databases. The authors reviewed the past development and the present state of medicalimage retrieval systems including text-based and content-based systems. In order to provide a more effective image retrieval service, the intelligent content-based retrieval systems combined with semantic systems are required. PMID:22509468

An improved computational-simulation system for interactive medicalimaging has been invented. The system displays high-resolution, three-dimensional-appearing images of anatomical objects based on data acquired by such techniques as computed tomography (CT) and magnetic-resonance imaging (MRI). The system enables users to manipulate the data to obtain a variety of views for example, to display cross sections in specified planes or to rotate images about specified axes. Relative to prior such systems, this system offers enhanced capabilities for synthesizing images of surgical cuts and for collaboration by users at multiple, remote computing sites.

... data can be used to support pediatric effectiveness claims for medicaldevices and pediatric device... support pediatric effectiveness claims for medicaldevices and pediatric device approvals or clearance, 2... HUMAN SERVICES Food and Drug Administration Pediatric MedicalDevices; Public Workshop; Reopening...

Biomedical Micro Electro Mechanical Systems (Bio-MEMS) have been applied to the development of a variety of health care related products including health Monitoring Systems (HMS) and Drug Delivery Systems (DDS). We focus on research to develop the new type compact medicaldevice used for blood sugar control. The new type compact medicaldevice comprises (1) a micropump system to extract blood using a pressure change occurred by electrolysis, (2) a platinum (Pt) electrode as a blood sugar sensor immobilized Glucose Oxidase (GOx) and attached to the gate electrode of Metal-Oxide-Semiconductor Field Effect Transistor (MOSFET) to detect the amount of glucose in extracted blood, and (3) a micropump system to inject insulin using a pressure change occurred by electrolysis. The device can extract blood in a few microliter through a painless microneedle with the micropump, which used the pressure change occurred by electrolysis. The liquid extraction ability of the micropump system through a microneedle, which is 3.8 mm in length and 100 μm in internal diameter, was measured. The wearable medicaldevice with using the micropump controlled by electrolysis could extract human blood at the speed of 0.15 μl/sec. If the wearable medicaldevice extracts human blood for 6 seconds, it is enough human blood volume to measure a glucose level, compared to the amount of commercial based glucose level monitor. The compact medicaldevice with the air bubble that occurred by electrolysis could inject insulin at the speed of 6.15μl/sec.

The first medicalimages produced using x-rays appeared less than a year after the discovery of x-rays by Wilhelm Roentgen in 1895. For over a century x-ray projection radiography has been and continues to be the most widely used diagnostic imaging modality. For over seventy years mathematics and computational methods were used in a general way for image processing and analysis. The really challenging mathematical and computational problems did not emerge until the 1970s with the beginning of computed tomography (CT) to produce images popularly known as CAT (computer-assisted tomography) scans. This was followed rapidly by positron-emission tomography (PET) and single photon emission computed tomography (SPECT). Magnetic resonance imaging (MRI) emerged in the 1980s and is in many ways the most informative medicalimaging methodology. Computer-based mathematical methods are fundamental to the success of these imaging modalities, and are increasingly important in several other novel imaging techniques. The technologies involved in each modality are competely different, have varying diagnostic value, and are described by different fundamental equations. The common underlying theme is that of the reconstruction of important characteristics of medical interest from indirect measurements. Several of these methodologies for visualizing internal body anatomy and function will be discussed and related to the evolution of computational capabilities. This brings out aspects of these biomedical imaging technologies where a deeper understanding is needed, and to frontiers where future advances are likely to come from continued research in physics jointly with the mathematical sciences.

Ultrawide band (UWB) microwave imaging is a promising method for the detection of early stage breast cancer, based on the large contrast in electrical parameters between malignant tumour tissue and the surrounding normal breast-tissue. In this paper, the detection and imaging of a malignant tumour are performed through a tomographic based microwave system and signal processing. Simulations of the proposed system are performed and postimage processing is presented. Signal processing involves the extraction of tumour information from background information and then image reconstruction through the confocal method delay-and-sum algorithms. Ultimately, the revision of time-delay and the superposition of more tumour signals are applied to improve accuracy. PMID:25379515

Image encryption is an effective approach for providing security and privacy protection for medicalimages. This paper introduces a new lossless approach, called EdgeCrypt, to encrypt medicalimages using the information contained within an edge map. The algorithm can fully protect the selected objects/regions within medicalimages or the entire medicalimages. It can also encrypt other types of images such as grayscale images or color images. The algorithm can be used for privacy protection in the real-time medical applications such as wireless medical networking and mobile medical services. PMID:19965008

In 1991, the NRC, Division of Industrial and Medical Nuclear Safety, began a program to evaluate the use of probabilistic risk assessment (PRA) in regulating medicaldevices. This program represents an initial step in an overall plant to evaluate the use of PRA in regulating the use of nuclear by-product materials. The NRC envisioned that the use of risk analysis techniques could assist staff in ensuring that the regulatory approach was standardized, understandable, and effective. Traditional methods of assessing risk in nuclear power plants may be inappropriate to use in assessing the use of by-product devices. The approaches used in assessing nuclear reactor risks are equipment-oriented. Secondary attention is paid to the human component, for the most part after critical system failure events have been identified. This paper describes the risk methodology developed by Lawrence Livermore National Laboratory (LLNL), initially intended to assess risks associated with the use of the Gamma Knife, a gamma stereotactic radiosurgical device. For relatively new medicaldevices such as the Gamma Knife, the challenge is to perform a risk analysis with very little quantitative data but with an important human factor component. The method described below provides a basic approach for identifying the most likely risk contributors and evaluating their relative importance. The risk analysis approach developed for the Gamma Knife and described in this paper should be applicable to a broader class of devices in which the human interaction with the device is a prominent factor. In this sense, the method could be a prototypical model of nuclear medical or industrial device risk analysis.

The academic medical center is faced with the unique challenge of meeting the multi-faceted needs of both a modern healthcare organization and an academic institution, The need for security to protect patient information must be balanced by the academic freedoms expected in the college setting. The Albany Medical Center, consisting of the Albany Medical College and the Albany Medical Center Hospital, was challenged with implementing a solution that would preserve the availability, integrity and confidentiality of business, patient and research data stored on mobile devices. To solve this problem, Albany Medical Center implemented a mobile encryption suite across the enterprise. Such an implementation comes with complexities, from performance across multiple generations of computers and operating systems, to diversity of application use mode and end user adoption, all of which requires thoughtful policy and standards creation, understanding of regulations, and a willingness and ability to work through such diverse needs. PMID:19382736

The research in this program involved theoretical investigations of the transport of charge in graphene and small heterostructure devices. There is an important trend toward imaging electronic systems in real space, with the goal of understanding the specifics of individual samples rather than settling for ensemble and statistical descriptions. For example one of our goals has been the understanding of scanning probe microscopy (SPM) imaging of systems in which the motion of the carriers is restricted to two degrees of freedom, such as in grapheme and the two dimensional electron (and hole) gas (2DEGs and 2DHGs) in GaAs/AlGaAs heterostructures, or when the motion is restricted to one degree of freedom as in nanowires. SPM imaging uses the tip of a movable charged probe to alter the electrons locally, depleting or alternatively increasing the amount of charges in the electron gas just below the tip results in a change to the flow pattern of the charge. The focus of this research was on understanding how the tunable tip affects functional aspects of the device that can be used to understand electronic and transport properties. For instance, scanning over the device while measuring the conductance results in conductance maps, an imaging of the charge transport. This imaging is often semi-direct and requires theory and interpretation to extract all that can be deduced about the underlying physical quantities.

Survey responses from 48 perinatal nurses found that most learned about medicaldevices by reading manuals; 75% had received inservice training; and 95% learned from other staff. Inadequate knowledge was related to fear of causing patient harm. Initial learning method influenced what was learned, and hands-on experience was considered efficacious.…

... beginning at 7:30 a.m. Non-U.S. citizens are subject to additional security screening, and they should... in the retention of blood, tissue, and other biological debris (soil) in reusable medicaldevices. This soil can allow microbes to survive the high level disinfection or sterilization...

This paper introduces the risk classification and listing way of medicaldevices in the United States, and according to the contents in various situations, FDA provides the requirements for clinical evaluation. At the same time, through the comparative study on the similarities and differences between USA and our country of the clinical evaluation, the paper puts forward some suggestions. PMID:26904887

Biomaterials used for medicaldevices must be thoroughly tested according to ISO 10993 before their introduction so that any negative effects on the body are known about and prevented. By using in vitro laboratory tests, dangers for patients and unnecessary animal experiments can be avoided. Here, in vitro tests for cell compatibility (cytotoxicity) and blood compatibility (haemocompatibility) are described. PMID:18605289

The Food and Drug Administration (FDA) is classifying the beta-glucan serological reagent device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the MedicalDevice Amendments of 1976 (the 1976 amendments), the Safe MedicalDevices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the MedicalDevice User Fee and Modernization Act of 2002. The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device. PMID:15386877

In recent times, there has been an unprecedented level of public interest and active debate regarding the regulation of medicaldevices. This is in light of the topical, rather dissimilar, incidents involving poly-implant-prothèse (PIP) breast and metal-on-metal hip implants. Although medicines and devices are regulated under European Union (EU) law, the regulatory regimes are very different and some have argued that features of the pharmaceutical regime should be applied to medicaldevices in the current review of the medicaldevices directives. Both medicines and certain devices need to have an assessment of their risks and benefits before being used in patients, and undergo subsequent monitoring for adverse events. However, there are significant differences between these two groups in terms of the number of products, the pattern of innovation and development, and the types of adverse events that arise from their use. This review will summarise the key issues through a comparison of how both are regulated and monitored. PMID:24532735

The Medical Information Bus (MIB) is a data communications standard for bedside patient connected medicaldevices. It is formally titled IEEE 1073 Standard for MedicalDevice Communications. MIB defines a complete seven layer communications stack for devices in acute care settings. All of the design trade-offs in writing the standard were taken to optimize performance in acute care settings. The key clinician based constraints on network performance are: (1) the network must be able to withstand multiple daily reconfigurations due to patient movement and condition changes; (2) the network must be 'plug-and-play' to allow clinicians to set up the network by simply plugging in a connector, taking no other actions; (3) the network must allow for unambiguous associations of devices with specific patients. A network of this type will be used by clinicians, thus giving complete, accurate, real time data from patient connected devices. This capability leads to many possible improvements in patient care and hospital cost reduction. The possible uses for comprehensive automatic data capture are only limited by imagination and creativity of clinicians adapting to the new hospital business paradigm. PMID:9600414

In nowadays it is a major objective to protect healthcare information against unauthorized access. Comparing conventional and electronic management of medicalimages the later one demands much more complex security measures. We propose a new scenario for watermark data buildup and embedding which is independent from the applied watermarking technology. In our proposed method the embedded watermark data is dependant on image and patient information too. The proposed watermark buildup method provides watermark information where it is small in size and represents a unique digest of the image and image related data. The embedded data can be considered unique with high probability even if the same algorithm was used in different medical information systems. Described procedures ensure new, more secure links between image and related data, offering further perspectives in smartcard implementations. PMID:14664001

While X-ray image intensifiers (XII), storage phosphor screens and film-screen systems are still the work horses of medicalimaging, large flat panel solid state detectors using either scintillators and amorphous silicon photo diode arrays (FD-Si), or direct X-ray conversion in amorphous selenium are reaching maturity. The main advantage with respect to image quality and low patient dose of the XII and FD-Si systems is caused by the rise of the Detector Quantum Efficiency originating from the application of thick needle-structured phosphor X-ray absorbers. With the detectors getting closer to an optimal state, further progress in medical X-ray imaging requires an improvement of the usable source characteristics. The development of clinical monochromatic X-ray sources of high power would not only allow an improved contrast-to-dose ratio by allowing smaller average photon energies in applications but would also lead to new imaging techniques.

Fractal geometry has been applied widely in the analysis of medicalimages to characterize the irregular complex tissue structures that do not lend themselves to straightforward analysis with traditional Euclidean geometry. In this study, we treat the nonfractal behaviour of medicalimages over large-scale ranges by considering their box-counting fractal dimension as a scale-dependent parameter rather than a single number. We describe this approach in the context of the more generalized Rényi entropy, in which we can also compute the information and correlation dimensions of images. In addition, we describe and validate a computational improvement to box-counting fractal analysis. This improvement is based on integral images, which allows the speedup of any box-counting or similar fractal analysis algorithm, including estimation of scale-dependent dimensions. Finally, we applied our technique to images of invasive breast cancer tissue from 157 patients to show a relationship between the fractal analysis of these images over certain scale ranges and pathologic tumour grade (a standard prognosticator for breast cancer). Our approach is general and can be applied to any medicalimaging application in which the complexity of pathological image structures may have clinical value. PMID:24023588

Wavelet transforms have emerged as a powerful tool in image fusion. However, the study and analysis of medicalimage fusion is still a challenging area of research. Therefore, in this paper, we propose a multiscale fusion of multimodal medicalimages in wavelet domain. Fusion of medicalimages has been performed at multiple scales varying from minimum to maximum level using maximum selection rule which provides more flexibility and choice to select the relevant fused images. The experimental analysis of the proposed method has been performed with several sets of medicalimages. Fusion results have been evaluated subjectively and objectively with existing state-of-the-art fusion methods which include several pyramid- and wavelet-transform-based fusion methods and principal component analysis (PCA) fusion method. The comparative analysis of the fusion results has been performed with edge strength (Q), mutual information (MI), entropy (E), standard deviation (SD), blind structural similarity index metric (BSSIM), spatial frequency (SF), and average gradient (AG) metrics. The combined subjective and objective evaluations of the proposed fusion method at multiple scales showed the effectiveness and goodness of the proposed approach. PMID:24453868

A surgical intervention raises additional requirements to a medicaldevice network, be it security concerns or the demand for just-in-time integration of an additional devices. The German national flagship project OR.NET aims to satisfy these requirements by defining, implementing and validating an integration solution for safe and dynamic networking. This work presents an approach to incorporate imaging related medicaldevices into a dynamic plug and play operating room (OR) network utilizing the existing Digital Imaging and Communications in Medicine (DICOM) protocol. The presented approach was created as part of the OR.NET project to realize the integration of DICOM devices into the developed infrastructure, both in regard to newly created DICOM devices with direct support of the OR.NET protocol and the integration of existing DICOM devices (e.g. image archives) employing a gateway. Preliminary evaluation results indicate that the approach is viable and that no critical transmission delays are introduced by the prototypical gateway implementation. PMID:26736608

Performance assurance (PA) is an integral component of clinical engineering medicaldevice risk management. For that reason, the clinical engineering (CE) community has made concerted efforts to define appropriate risk factors and develop quantitative risk models for efficient data processing and improved PA program operational decision making. However, a common framework that relates the various processes of a quantitative risk system does not exist. This article provides a perspective that focuses on medicaldevice quality and risk-based elements of the PA program, which include device inclusion/exclusion, schedule optimization, and inspection prioritization. A PA risk management framework is provided, and previous quantitative models that have contributed to the advancement of PA risk management are examined. A general model for quantitative risk systems is proposed, and further perspective on possible future directions in the area of PA technology is also provided. PMID:26618842

Over the past decade, rapid development of imaging technologies has resulted in the introduction of improved imagingdevices, such as multi-modality scanners that produce combined positron emission tomography-computed tomography (PET-CT) images. The adoption of picture archiving and communication systems (PACS) in hospitals have dramatically improved the ability to digitally share medicalimage studies via portable storage, mobile devices and the Internet. This has in turn led to increased productivity, greater flexibility, and improved communication between hospital staff, referring physicians, and outpatients. However, many of these sharing and viewing capabilities are limited to proprietary vendor-specific applications. Furthermore, there are still interoperability and deployment issues which reduce the rate of adoption of such technologies, thus leaving many stakeholders, particularly outpatients and referring physicians, with access to only traditional still images with no ability to view or interpret the data in full. In this paper, we present a distribution architecture for medicalimage display across numerous devices and media, which uses a preprocessor and an in-built networking framework to improve compatibility and promote greater accessibility of medical data. Our INVOLVE2 system consists of three main software modules: 1) a preprocessor, which collates and converts imaging studies into a compressed and distributable format; 2) a PACS-compatible workflow for self-managing distribution of medical data, e.g. via CD USB, network etc; 3) support for potential mobile and web-based data access. The focus of this study was on cultivating patient-centric care, by allowing outpatient users to comfortably access and interpret their own data. As such, the image viewing software included on our cross-platform CDs was designed with a simple and intuitive user-interface (UI) for use by outpatients and referring physicians. Furthermore, digital image access via

Over the last few decades, the achievements and progress in the field of medicalimaging have dramatically enhanced the early detection and treatment of many pathological conditions. The development of new imaging modalities, especially non-ionising ones, which will improve prognosis, is of crucial importance. A number of novel imaging modalities have been developed but they are still in the initial stages of development and serious drawbacks obstruct them from offering their benefits to the medical field. In the 21 st century, it is believed that nanotechnology will highly influence our everyday life and dramatically change the world of medicine, including medicalimaging. Here we discuss how nanotechnology, which is still in its infancy, can improve Terahertz (THz) imaging, an emerging imaging modality, and how it may find its way into real clinical applications. THz imaging is characterised by the use of non-ionising radiation and although it has the potential to be used in many biomedical fields, it remains in the field of basic research. An extensive review of the recent available literature shows how the current state of this emerging imaging modality can be transformed by nanotechnology. Innovative scientific concepts that use nanotechnology-based techniques to overcome some of the limitations of the use of THz imaging are discussed. We review a number of drawbacks, such as a low contrast mechanism, poor source performance and bulky THz systems, which characterise present THz medicalimaging and suggest how they can be overcome through nanotechnology. Better resolution and higher detection sensitivity can also be achieved using nanotechnology techniques. PMID:24555052

Superparamagnetic iron oxide nanoparticles have been established as sensitive probes for magnetic resonance imaging (MRI). While the majority of specific nanosensors are based on sterically stabilized iron oxide particles, the focus of this review is on the use of very small iron oxide particles (VSOPs) that are electrostatically stabilized by an anionic citrate acid shell. We used VSOPs to develop target-specific as well as protease-activatable nanosensors for molecular MRI. PMID:19846442

The medicalimaging facility of the ESRF is devoted to human coronary angiography, computed tomography, diffraction enhanced imaging (DEI), bronchography, and also radiation therapy programs. Most of the imaging is performed in a satellite building located at 150 m from the wiggler source (H. Elleaume et al., Nucl. Instr. and Meth. A 428 (1999) 513). A multi-purpose device known as the Patient Positioning System (PPS or medical chair) has been designed to perform in different modes of research on patients. This device operates in the angiography mode, with alternating up and down movements in 1.6 s cycles over a period of about 30 s. The tomography mode is used mainly for the imaging of the brain. It consists of turning the patient around an axis perfectly perpendicular to the beam plane. A dual-energy scan involves two rotations with one image recorded each turn at a different energy (Phys. Med. Biol. 45 (2000) L39). The first angiography imaging on patients was undertaken in January 2000 after successful pre-clinical tests on animals.

Manufacturers often express the performance of a 3D imagingdevice in various non-uniform ways for the lack of internationally recognized standard requirements for metrological parameters able to identify the capability of capturing a real scene. For this reason several national and international organizations in the last ten years have been developing protocols for verifying such performance. Ranging from VDI/VDE 2634, published by the Association of German Engineers and oriented to the world of mechanical 3D measurements (triangulation-based devices), to the ASTM technical committee E57, working also on laser systems based on direct range detection (TOF, Phase Shift, FM-CW, flash LADAR), this paper shows the state of the art about the characterization of active range devices, with special emphasis on measurement uncertainty, accuracy and resolution. Most of these protocols are based on special objects whose shape and size are certified with a known level of accuracy. By capturing the 3D shape of such objects with a range device, a comparison between the measured points and the theoretical shape they should represent is possible. The actual deviations can be directly analyzed or some derived parameters can be obtained (e.g. angles between planes, distances between barycenters of spheres rigidly connected, frequency domain parameters, etc.). This paper shows theoretical aspects and experimental results of some novel characterization methods applied to different categories of active 3D imagingdevices based on both principles of triangulation and direct range detection.

PurposeThe purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medicaldevices, from various manufacturers, used in interventional radiology.MethodsThe labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.ResultsA total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm.The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.ConclusionsOur results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medicaldevices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed.

Two dimensional hydrogenated amorphous silicon (a-Si:H) pixel arrays are good candidates as flat-panel imagers for applications in medicalimaging. Various performance characteristics of these imagers are reviewed and compared with currently used equipments. An important component in the a-Si:H imager is the scintillator screen. A new approach for fabrication of high resolution CsI(Tl) scintillator layers, appropriate for coupling to a-Si:H arrays, are presented. For nuclear medicine applications, a new a-Si:H based gamma camera is introduced and Monte Carlo simulation is used to evaluate its performance.

The Food and Drug Administration (FDA) is classifying the coronary vascular physiologic simulation software device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the coronary vascular physiologic simulation software device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:26495515

The Food and Drug Administration (FDA) is classifying the Factor V Leiden deoxyribonucleic acid (DNA) mutation detections systems device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the MedicalDevice Amendments of 1976 (the 1976 amendments), the Safe MedicalDevices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the MedicalDevice User Fee and Modernization Act of 2002. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device. PMID:15025053

Mutual information (MI)-based registration, which uses MI as the similarity measure, is a representative method in medicalimage registration. It has an excellent robustness and accuracy, but with the disadvantages of a large amount of calculation and a long processing time. In this paper, by computing the medicalimage moments, the centroid is acquired. By applying fuzzy c-means clustering, the coordinates of the medicalimage are divided into two clusters to fit a straight line, and the rotation angles of the reference and floating images are computed, respectively. Thereby, the initial values for registering the images are determined. When searching the optimal geometric transformation parameters, we put forward the two new concepts of fuzzy distance and fuzzy signal-to-noise ratio (FSNR), and we select FSNR as the similarity measure between the reference and floating images. In the experiments, the Simplex method is chosen as multi-parameter optimisation. The experimental results show that this proposed method has a simple implementation, a low computational cost, a fast registration and good registration accuracy. Moreover, it can effectively avoid trapping into the local optima. It is adapted to both mono-modality and multi-modality image registrations. PMID:21442490

Radiological imaging is fundamental within the healthcare industry and has become routinely adopted for diagnosis, disease monitoring and treatment planning. With the advent of digital imaging modalities and the rapid growth in both diagnostic and therapeutic imaging, the ability to be able to harness this large influx of data is of paramount importance. The Oncology MedicalImage Database (OMI-DB) was created to provide a centralized, fully annotated dataset for research. The database contains both processed and unprocessed images, associated data, and annotations and where applicable expert determined ground truths describing features of interest. Medicalimaging provides the ability to detect and localize many changes that are important to determine whether a disease is present or a therapy is effective by depicting alterations in anatomic, physiologic, biochemical or molecular processes. Quantitative imaging features are sensitive, specific, accurate and reproducible imaging measures of these changes. Here, we describe an extension to the OMI-DB whereby a range of imaging features and descriptors are pre-calculated using a high throughput approach. The ability to calculate multiple imaging features and data from the acquired images would be valuable and facilitate further research applications investigating detection, prognosis, and classification. The resultant data store contains more than 10 million quantitative features as well as features derived from CAD predictions. Theses data can be used to build predictive models to aid image classification, treatment response assessment as well as to identify prognostic imaging biomarkers.

Three-dimensional image reconstruction in medical applications (PET or X-ray CT) utilizes sophisticated filter algorithms to linear trajectories of coincident photon pairs or x-rays. The goal is to reconstruct an image of an emitter density distribution. In a similar manner, tracks in particle physics originate from vertices that need to be distinguished from background track combinations. In this study it is investigated if vertex reconstruction in high energy proton collisions may benefit from medicalimaging methods. A new method of vertex finding, the MedicalImaging Vertexer (MIV), is presented based on a three-dimensional filtered backprojection algorithm. It is compared to the open-source RAVE vertexing package. The performance of the vertex finding algorithms is evaluated as a function of instantaneous luminosity using simulated LHC collisions. Tracks in these collisions are described by a simplified detector model which is inspired by the tracking performance of the LHC experiments. At high luminosities (25 pileup vertices and more), the medicalimaging approach finds vertices with a higher efficiency and purity than the RAVE “Adaptive Vertex Reconstructor” algorithm. It is also much faster if more than 25 vertices are to be reconstructed because the amount of CPU time rises linearly with the number of tracks whereas it rises quadratically for the adaptive vertex fitter AVR.

We have proposed a type of mid-infrared (MIR) and far-infrared (FIR) dual-band imagingdevice, which employs the photon frequency upconversion concept in a GaN/AlGaN MIR and FIR dual-band detector integrated with a GaN/AlGaN violet light emitting diode. On the basis of the photoresponse of single-period GaN/AlGaN dual-band detectors, we present the detailed optimization of multiperiod GaN emitter/AlGaN barrier detectors and their applications to dual-band pixelless upconversion imaging. Satisfying images have been received through the analysis of the modulation transfer function and the upconversion efficiency in the GaN/AlGaN dual-band pixelless upconverters, which exhibit good image resolution, high quantum efficiency, and negligible cross talk. PMID:17700787

Infrared (IR) light filters developed by Lake Shore Cryotronics Inc. of Westerville, Ohio -- using SBIR funding from NASA s Jet Propulsion Laboratory and Langley Research Center -- employ porous silicon and metal mesh technology to provide optical filtration even at the ultra-low temperatures required by many IR sensors. With applications in the astronomy community, Lake Shore s SBIR-developed filters are also promising tools for use in terahertz imaging, the next wave of technology for applications like medicalimaging, the study of fragile artworks, and airport security.

Medicaldevice evaluation presents several unique challenges due to the great diversity and complexity of medicaldevices and their rapid technological evolution. There has been a variety of work conducted on the development of disease based registries and health surveillance systems in Saudi Arabia. However, the progress of medicaldevice registry systems and post-market medicaldevice surveillance systems remains in its infancy in Saudi Arabia and within the region. In 2007, a royal decree assigned the responsibility for regulating medicaldevices to the Saudi Food and Drug Authority (SFDA). Soon afterwards, the SFDA established the MedicalDevices National Registry (MDNR) to house medicaldevice information relating to manufacturers, agents, suppliers and end-users. The aim of this paper is to provide an overview on the MedicalDevice National Registry (MDNR) in Saudi Arabia and describe the current experience and future work of establishing a comprehensive medicaldevice registry and post-market surveillance system in Saudi Arabia. PMID:26152943

The large numbers of technologies currently incorporated into mobile devices transform them into excellent tools for capture and to manage the information, because of the increasing computing power and storage that allow to add many miscellaneous applications. In order to obtain benefits of these technologies, in the biomedical engineering field, it was developed a mobile information system for medical equipment management. The central platform for the system it's a mobile phone, which by a connection with a web server, it's capable to send and receive information relative to any medical equipment. Decoding a type of barcodes, known as QR-Codes, the management process is simplified and improved. These barcodes identified the medical equipments in a database, when these codes are photographed and decoded with the mobile device, you can access to relevant information about the medical equipment in question. This Project in it's actual state is a basic support tool for the maintenance of medical equipment. It is also a modern alternative, competitive and economic in the actual market.

The Food and Drug Administration (FDA) is publishing a final rule exempting from the premarket notification requirements the fluoroscopic compression device, a manual compression device that allows a radiologist to press on the abdomen during a fluoroscopic procedure without exposing his or her hand to the x-ray beam. The device is classified as an accessory to the image-intensified fluoroscopic x-ray system. FDA received a petition requesting an exemption for the F-Spoon device, a type of fluoroscopic manual compression device. FDA is expanding the exemption for this type of generic device to include other fluoroscopic compression devices. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA). PMID:11776279

Data in medicalimages is very large and therefore for storage and/or transmission of these images, compression is essential. A method is proposed which provides high compression ratios for radiographic images with no loss of diagnostic quality. In the approach an image is first compressed at a high compression ratio but with loss, and the error image is then compressed losslessly. The resulting compression is not only strictly lossless, but also expected to yield a high compression ratio, especially if the lossy compression technique is good. A neural network vector quantizer (NNVQ) is used as a lossy compressor, while for lossless compression Huffman coding is used. Quality of images is evaluated by comparing with standard compression techniques available. PMID:17281110

... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medicaldevice... medicaldevices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... reactivity of the human blood or blood component in the medicaldevice presents no significant health...

... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medicaldevice... medicaldevices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... reactivity of the human blood or blood component in the medicaldevice presents no significant health...

... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medicaldevice... medicaldevices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... reactivity of the human blood or blood component in the medicaldevice presents no significant health...

... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medicaldevice... medicaldevices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... reactivity of the human blood or blood component in the medicaldevice presents no significant health...

... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medicaldevice... medicaldevices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... reactivity of the human blood or blood component in the medicaldevice presents no significant health...

The Food and Drug Administration (FDA) is classifying the nasolacrimal compression device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:27295735

Biomedical device and medicine product manufacturing are long processes facing global competition. As technology evolves with time, the level of quality, safety and reliability increases simultaneously. Micro Computer Tomography (Micro CT) is a tool allowing a deep investigation of products: it can contribute to quality improvement. This article presents the numerous applications of Micro CT for medicaldevice and pharmaceutical packaging analysis. The samples investigated confirmed CT suitability for verification of integrity, measurements and defect detections in a non-destructive manner. PMID:25710902

Discussed are medical applications of ultrasound. The physics of the wave nature of ultrasound including its propagation and production, return by the body, spatial and contrast resolution, attenuation, image formation using pulsed echo ultrasound techniques, measurement of velocity and duplex scanning are described. (YP)

Medical ultrasonic imaging system designed to provide quantitative data on various flows of blood in chambers, blood vessels, muscles, and tissues of heart. Sensitive enough to yield readings on flows of blood in heart even when microspheres used as ultrasonic contrast agents injected far from heart and diluted by circulation of blood elsewhere in body.

For almost a decade, research has been conducted in many areas of science to develop medical simulation training devices and even comprehensive training systems. To propel the field, the Telemedicine and Advanced Technology Research Center (TATRC), an agency of the United States Army Medical Research Materiel Command (USAMRMC), has been managing a portfolio of research projects in the area of Medical Modeling and Simulation (MM&S) since 1999. Significant progress has made to identify and harness enabling technologies. Generally, these developments can be categorized in four areas: (1) PC-based interactive multimedia, (2) Digitally Enhanced Mannequins, (3) Virtual Workbench, or "part-task", simulators, and (4) Total Immersion Virtual Reality (TIVR). Many medical simulation-training systems have shown great potential to improve medical training, but the potential shown has been based largely on anecdotal feedback from informal user studies. Formal assessment is needed to determine the degree to which simulator(s) train medical skills and the degree to which skills learned on a simulator transfer to the practice of care. A robust methodology is required as a basis for these assessments. Several scientific workshops sponsored in 2001 focused on algorithm and metrics development in support of surgical simulation. Also in 2001, TATRC chartered a Simulation Working Group (SWG) to develop a robust methodology upon which to base an assessment of the effectiveness of simulation training devices and systems. After the terrorist attacks of September 11, 2001, attention was redirected for a period, and progress was delayed. In the summer of 2002, TATRC chartered a follow-on group called the Validation, Metrics and Simulation (VMAS) Committee. The poster will highlight and summarize the development of the methodology and identify validation studies to be conducted (supported by various funding sources and research programs). The interaction between TATRC and the National Capital

A microwave tomographic scanner for biomedical applications is presented. The scanner consists of a 64 element circular array with a useful diameter of 20 cm. Electronically scanning the transmitting and receiving antennas allows multiview measurements with no mechanical movement. Imaging parameters are appropriate for medical use: a spatial resolution of 7 mm and a contrast resolution of 1% for a measurement time of 3 s. Measurements on tissue-simulating phantoms and volunteers, together with numerical simulations, are presented to assess the system for absolute imaging of tissue distribution and for differential imaging of physiological, pathological, and induced changes in tissues. PMID:2329003

Medicaldevices have emerged as an important clinical option to treat certain serious diseases for which there are no equivalently effective surgical or pharmaceutical alternatives. Although all clinical activities impose high ethical standards of comportment to protect patients, medicaldevice R&D and product application have a number of relatively unique aspects that distinguish them from other technologies such as pharmaceuticals. These include the following: R&D project selection; regulatory requirements, and their intended and unintended effects; when is a new product design sufficiently safe and effective for routine use in patients; and, physician-industry relationships in the innovation process in the context of real or perceived conflict of interest (COI). Each of these factors has implications for the delivery of care, health care leadership, and patient well-being. PMID:23217435

Witricity is a newly developed technique for wireless energy transfer. This paper presents a frequency adjustable witricity system to power medical sensors and implantable devices. New witricity resonators are designed for both energy transmission and reception. A prototype platform is described, including an RF power source, two resonators with new structures, and inductively coupled input and output stages. In vitro experiments, both in open air and using a human head phantom consisting of simulated tissues, are employed to verify the feasibility of this platform. An animal model is utilized to evaluate in vivo energy transfer within the body of a laboratory pig. Our experiments indicate that witricity is an effective new tool for providing a variety of medical sensors and devices with power. PMID:19964948

A new object-oriented MedicalDevice Data Language (MDDL) has been developed by the P1073 Medical Information Bus (MIB) Standard Committee, under the auspices of the Engineering in Biology and Medicine Society (EMBS) of the Institute of Electronic and Electrical Engineers (IEEE). The MDDL treats devices, host computers, persons and parameters as objects, and provides methods for describing and passing messages between objects. An elegant method of specifying parameter attributes incorporates the inheritance and encapsulation qualities common to object-oriented languages. Existing standards for device, parameter and attribute nomenclatures are used to represent MDDL components whenever possible. The MDDL provides a rich and extensible method for standardized host-device communications. PMID:2373946

While Australia has enjoyed the benefits of a National Medicines Policy (NMP) for many years, there is no equivalent national policy for medicaldevices. This is despite an established medicaldevice legal framework that spans multiple departments across the Australian Government. The existing NMP offers an effective and proven benchmark for the development of a national medicaldevices policy. The four NMP principles of industry, standards, access and use are applicable to all phases of the medicaldevice life-cycle and align with existing medicaldevices policy. This article proposes that Australia's approach to medicaldevices stands to benefit from an equivalent whole-of-government policy. PMID:20169801

As a result of the enthusiastic support from the Australian biomedical, medical and clinical communities, the Australian Synchrotron is constructing a world-class facility for medical research, the `Imaging and Medical Beamline'. The IMBL began phased commissioning in late 2008 and is scheduled to commence the first clinical research programs with patients in 2011. It will provide unrivalled x-ray facilities for imaging and radiotherapy for a wide range of research applications in diseases, treatments and understanding of physiological processes. The main clinical research drivers are currently high resolution and sensitivity cardiac and breast imaging, cell tracking applied to regenerative and stem cell medicine and cancer therapies. The beam line has a maximum source to sample distance of 136 m and will deliver a 60 cm by 4 cm x-ray beam1—monochromatic and white—to a three storey satellite building fully equipped for pre-clinical and clinical research. Currently operating with a 1.4 Tesla multi-pole wiggler, it will upgrade to a 4.2 Tesla device which requires the ability to handle up to 21 kW of x-ray power at any point along the beam line. The applications envisaged for this facility include imaging thick objects encompassing materials, humans and animals. Imaging can be performed in the range 15-150 keV. Radiotherapy research typically requires energies between 30 and 120 keV, for both monochromatic and broad beam.

As a result of the enthusiastic support from the Australian biomedical, medical and clinical communities, the Australian Synchrotron is constructing a world-class facility for medical research, the 'Imaging and Medical Beamline'. The IMBL began phased commissioning in late 2008 and is scheduled to commence the first clinical research programs with patients in 2011. It will provide unrivalled x-ray facilities for imaging and radiotherapy for a wide range of research applications in diseases, treatments and understanding of physiological processes. The main clinical research drivers are currently high resolution and sensitivity cardiac and breast imaging, cell tracking applied to regenerative and stem cell medicine and cancer therapies. The beam line has a maximum source to sample distance of 136 m and will deliver a 60 cm by 4 cm x-ray beam1 - monochromatic and white - to a three storey satellite building fully equipped for pre-clinical and clinical research. Currently operating with a 1.4 Tesla multi-pole wiggler, it will upgrade to a 4.2 Tesla device which requires the ability to handle up to 21 kW of x-ray power at any point along the beam line. The applications envisaged for this facility include imaging thick objects encompassing materials, humans and animals. Imaging can be performed in the range 15-150 keV. Radiotherapy research typically requires energies between 30 and 120 keV, for both monochromatic and broad beam.

At long ranges and under low visibility conditions, Advanced Optoelectronic Device provides the signal-to-noise ratio and image quality in the Short-wave Infra-red - SWIR (wavelengths between 1,1 ÷2,5 μm), significantly better than in the near wave infrared - NWIR and visible spectral bands [1,2]. The quality of image is nearly independent of the polarization in the incoming light, but it is influenced by the relative movement between the optical system and the observer (the operators' handshake), and the movement towards the support system (land and air vehicles). All these make it difficult to detect objectives observation in real time. This paper presents some systems enhance which the ability of observation and sighting through the optical systems without the use of the stands, tripods or other means. We have to eliminate the effect of "tremors of the hands" and the vibration in order to allow the use of optical devices by operators on the moving vehicles on land, on aircraft, or on boats, and to provide additional comfort for the user to track the moving object through the optical system, without losing the control in the process of detection and tracking. The practical applications of stabilization image process, in SWIR, are the most advanced part of the optical observation systems available worldwide [3,4,5]. This application has a didactic nature, because it ensures understanding by the students about image stabilization and their participation in research.

The Food and Drug Administration (FDA) is reclassifying three anesthesiology preamendments devices from class III (premarket approval) into class II (special controls). FDA is also identifying the special controls that the agency believes will reasonably ensure the safety and effectiveness of the devices. This reclassification is being undertaken on the agency's own initiative based on new information under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe MedicalDevices Act of 1990 and the FDA Modernization Act of 1997. PMID:11776278

The purpose of this paper is to introduce a new and important conceptual framework of software design for the medicalimaging community using design patterns. Use cases are created to summarize operational scenarios of clinicians using the system to complete certain tasks such as image segmentation. During design the Unified Modeling Language is used to translate the use cases into modeling diagrams that describe how the system functions. Next, design patterns are applied to build models that describe how software components interoperate to deliver that functionality. The software components are implemented using the Java language, CORBA architecture, and other web technologies. The biomedical image information system is used in epilepsy neurosurgical planning and diagnosis. This article proposes the use of proven software design models for solving medicalimaging informatics design problems. Design patterns provide an excellent vehicle to leverage design solutions that have worked in the past to solve the problems we face in building user-friendly, reliable, and efficient information systems. This work introduces this new technology for building increasing complex medicalimage information systems. The rigorous application of software design techniques is essential in building information systems that are easy to use, rich in functionality, maintainable, reliable, and updatable.

Box counting (BC) is widely used to estimate the fractal dimension (fd) of medicalimages on the basis of a finite set of pixel data. The fd is then used as a feature to discriminate between healthy and unhealthy conditions. We show that BC is ineffective when used on small data sets and give examples of published studies in which researchers have obtained contradictory and flawed results by using BC to estimate the fd of data-limited medicalimages. We present a new method for estimating fd of data-limited medicalimages. In the new method, fractal interpolation functions (FIFs) are used to generate self-affine models of the underlying image; each model, upon discretization, approximates the original data points. The fd of each FIF is analytically evaluated. The mean of the fds of the FIFs is the estimate of the fd of the original data. The standard deviation of the fds of the FIFs is a confidence measure of the estimate. The goodness-of-fit of the discretized models to the original data is a measure of self-affinity of the original data. In a test case, the new method generated a stable estimate of fd of a rib edge in a standard chest x-ray; box counting failed to generate a meaningful estimate of the same image.

Paper addresses the computational aspects of extracting important features directly from compressed images for the purpose of aiding biomedical image retrieval based on content. The proposed method for treatment of compressed medical archives follows the JPEG compression standard and exploits algorithm based on spacial analysis of the image cosine spectrum coefficients amplitude and location. The experiments on modality-specific archive of osteoarticular images show robustness of the method based on measured spectral spatial statistics. The features, which were based on the cosine spectrum coefficients' values, could satisfy different types of queries' modalities (MRI, US, etc), which emphasized texture and edge properties. In particular, it has been shown that there is wealth of information in the AC coefficients of the DCT transform, which can be utilized to support fast content-based image retrieval. The computational cost of proposed signature generation algorithm is low. Influence of conventional and the state-of-the-art compression techniques based on cosine and wavelet integral transforms on the performance of content-based medicalimage retrieval has been also studied. We found no significant differences in retrieval efficiencies for non-compressed and JPEG2000-compressed images even at the lowest bit rate tested.

The research mission is the development of computer assisted diagnostic (CAD) methods for improved diagnosis of medicalimages including digital x-ray sensors and tomographic imaging modalities. The CAD algorithms include advanced methods for adaptive nonlinear filters for image noise suppression, hybrid wavelet methods for feature segmentation and enhancement, and high convergence neural networks for feature detection and VLSI implementation of neural networks for real time analysis. Other missions include (1) implementation of CAD methods on hospital based picture archiving computer systems (PACS) and information networks for central and remote diagnosis and (2) collaboration with defense and medical industry, NASA, and federal laboratories in the area of dual use technology conversion from defense or aerospace to medicine.

Bacteria colonization on medicaldevices remains one of the most serious complications following implantation. Traditional antibiotic treatment has proven ineffective, creating an increasingly high number of drug-resistant bacteria. Polymeric medicaldevices represent a significant portion of the total medicaldevices used today due to their excellent mechanical properties (such as durability, flexibility, etc). However, many polymers (such as polyvinyl chloride (PVC), polyurethane (PU) and silicone) become readily colonized and infected by bacteria immediately after use. Therefore, in this study, a novel antimicrobial coating was developed to inhibit bacterial growth on PVC, PU and silicone. Specifically, here, the aforementioned polymeric substrates were coated with selenium (Se) nanoparticles in situ. The Se-coated substrates were characterized using scanning electron microscopy, energy dispersive x-ray spectroscopy and bacteria assays. Most importantly, bacterial growth was significantly inhibited on the Se-coated substrates compared to their uncoated counterparts. The reduction of bacteria growth directly correlated with the density of Se nanoparticles on the coated substrate surfaces. In summary, these results demonstrate that Se should be further studied as a novel anti-bacterial polymeric coating material which can decrease bacteria functions without the use of antibiotics.

Remote point-of-care is expected to revolutionize the modern medical practice, and many efforts have been made for the development of wireless health monitoring systems for continuously detecting the physiological signals of patients. To make the remote point-of-care generally accepted and widely used, it is necessary to develop cost-effective and durable wireless health monitoring systems. Printing technique will be helpful for the fabrication of high-quality and low-cost medicaldevices and systems because it allows high-resolution and high-speed fabrication, low material consumption and nano-sized patterning on both flexible and rigid substrates. Furthermore, application of thermoelectric generators can replace conventional batteries as the power sources for wireless health monitoring systems because thermoelectric generators can convert the wasted heat or the heat from nature into electricity which is required for the operation of the wireless health monitoring systems. In this research, we propose the concept of printable thermoelectric devices and conductive patterns for the realization of more portable and cost-effective medicaldevices. To print thermoelectric generators and conductive patterns on substrates, printing inks with special characteristics should be developed. For the development of thermoelectric inks, nano-structured thermoelectric materials are synthesized and characterized; and for the development of conductive inks, two kinds of surface treated carbon nanotubes are used as active materials.

Bacteria colonization on medicaldevices remains one of the most serious complications following implantation. Traditional antibiotic treatment has proven ineffective, creating an increasingly high number of drug-resistant bacteria. Polymeric medicaldevices represent a significant portion of the total medicaldevices used today due to their excellent mechanical properties (such as durability, flexibility, etc). However, many polymers (such as polyvinyl chloride (PVC), polyurethane (PU) and silicone) become readily colonized and infected by bacteria immediately after use. Therefore, in this study, a novel antimicrobial coating was developed to inhibit bacterial growth on PVC, PU and silicone. Specifically, here, the aforementioned polymeric substrates were coated with selenium (Se) nanoparticles in situ. The Se-coated substrates were characterized using scanning electron microscopy, energy dispersive x-ray spectroscopy and bacteria assays. Most importantly, bacterial growth was significantly inhibited on the Se-coated substrates compared to their uncoated counterparts. The reduction of bacteria growth directly correlated with the density of Se nanoparticles on the coated substrate surfaces. In summary, these results demonstrate that Se should be further studied as a novel anti-bacterial polymeric coating material which can decrease bacteria functions without the use of antibiotics. PMID:23519147

The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled ``MedicalDevices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton'' that published in the Federal Register on February 24, 2015. FDA is republishing to correct an inadvertent omission of information. FDA is classifying the powered lower extremity exoskeleton into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the powered lower extremity exoskeleton's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:25985478

Image registration is a basic task in medicalimage processing applications like group analysis and atlas construction. Similarity measure is a critical ingredient of image registration. Intensity distortion of medicalimages is not considered in most previous similarity measures. Therefore, in the presence of bias field distortions, they do not generate an acceptable registration. In this paper, we propose a sparse based similarity measure for mono-modal images that considers non-stationary intensity and spatially-varying distortions. The main idea behind this measure is that the aligned image is constructed by an analysis dictionary trained using the image patches. For this purpose, we use "Analysis K-SVD" to train the dictionary and find the sparse coefficients. We utilize image patches to construct the analysis dictionary and then we employ the proposed sparse similarity measure to find a non-rigid transformation using free form deformation (FFD). Experimental results show that the proposed approach is able to robustly register 2D and 3D images in both simulated and real cases. The proposed method outperforms other state-of-the-art similarity measures and decreases the transformation error compared to the previous methods. Even in the presence of bias field distortion, the proposed method aligns images without any preprocessing. PMID:27085311

A device for imaging scenes with a very large range of intensity having a pair of polarizers, a primary lens, an attenuating mask, and an imagingdevice optically connected along an optical axis. Preferably, a secondary lens, positioned between the attenuating mask and the imagingdevice is used to focus light on the imagingdevice. The angle between the first polarization direction and the second polarization direction is adjustable.

... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 MedicalDevices; Immunology and Microbiology... delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows: PART...

... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 MedicalDevices; Immunology and Microbiology... delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows: PART...

Electronic medical implants have collectively transformed the diagnosis and treatment of many diseases, but have many inherent limitations. Electronic implants require invasive surgeries, operate in challenging microenvironments, and are susceptible to bacterial infection and persistent inflammation. Novel materials and nonconventional device fabrication strategies may revolutionize the way electronic devices are integrated with the body. Ingestible electronic devices offer many advantages compared with implantable counterparts that may improve the diagnosis and treatment of pathologies ranging from gastrointestinal infections to diabetes. This review summarizes current technologies and highlights recent materials advances. Specific focus is dedicated to next-generation materials for packaging, circuit design, and on-board power supplies that are benign, nontoxic, and even biodegradable. Future challenges and opportunities are also highlighted. PMID:26403162

The hip replacement is a surgical procedure to replace the femoral head and acetabulum with prosthetic implants to improve function, increase mobility, and relieve pain caused by damage from disorders such as osteoarthritis and fractures. In recent years, we have seen several recalls of poorly functioning implant systems, most recently, the Johnson and Johnson (J&J) Articular Surface Replacement device. Product recalls are often the results of premature failure of implants requiring additional surgery to exchange the failed device. This raises many questions - technical, medical, regulatory, ethical, and legal - that ultimately put patients at risk, compromise confidence in medicine and regulatory agencies, and important relationships including those between the physician-patient and physician-industry. Where do the responsibilities lie for the patients' suffering, morbidity, and costs of removing the failed device? This article discusses the current recall of the J&J implant, the responsibilities of the manufacturer, surgeons, and the regulatory agency. PMID:23741723

Equipping medicaldevices with long range telemetry opens completely new possibilities for emergency response, home care and remote diagnosis. Mobile communications nowadays seem to be a generally accepted part of our modern world, but bridging the gap between new (consumer-) technologies and medicaldevices still is a challenge today. Providing a telemetry link (GSM) is just the trivial part--ensuring security, reliability and service management are the more critical tasks that need to be addressed. Therefore, a complete system concept consists of an automatic fleet management (e.g. periodic device-initiated service calls) as well as customer relationship management (CRM), including technical service and a trouble-ticket system. PMID:12451860

The scale of interesting structures in medicalimages is space variant because of partial volume effects, spatial dependence of resolution in many imaging modalities, and differences in tissue properties. Existing segmentation methods either apply a single scale to the entire image or try fine-to-coarse/coarse-to-fine tracking of structures over multiple scales. While single scale approaches fail to fully recover the perceptually important structures, multi-scale methods have problems in providing reliable means to select proper scales and integrating information over multiple scales. A recent approach proposed by Elder and Zucker addresses the scale selection problem by computing a minimal reliable scale for each image pixel. The basic premise of this approach is that, while the scale of structures within an image vary spatially, the imaging system is fixed. Hence, sensor noise statistics can be calculated. Based on a model of edges to be detected, and operators to be used for detection, one can locally compute a unique minimal reliable scale at which the likelihood of error due to sensor noise is less than or equal to a predetermined threshold. In this paper, we improve the segmentation method based on the minimal reliable scale selection and evaluate its effectiveness with both simulated and actual medical data.

The impact of image pattern recognition on accessing large databases of medicalimages has recently been explored, and content-based image retrieval (CBIR) in medical applications (IRMA) is researched. At the present, however, the impact of image retrieval on diagnosis is limited, and practical applications are scarce. One reason is the lack of suitable mechanisms for query refinement, in particular, the ability to (1) restore previous session states, (2) combine individual queries by Boolean operators, and (3) provide continuous-valued query refinement. This paper presents a powerful user interface for CBIR that provides all three mechanisms for extended query refinement. The various mechanisms of man-machine interaction during a retrieval session are grouped into four classes: (1) output modules, (2) parameter modules, (3) transaction modules, and (4) process modules, all of which are controlled by a detailed query logging. The query logging is linked to a relational database. Nested loops for interaction provide a maximum of flexibility within a minimum of complexity, as the entire data flow is still controlled within a single Web page. Our approach is implemented to support various modalities, orientations, and body regions using global features that model gray scale, texture, structure, and global shape characteristics. The resulting extended query refinement has a significant impact for medical CBIR applications. PMID:17497197

Pathology is a medical subspecialty that practices the diagnosis of disease. Microscopic examination of tissue reveals information enabling the pathologist to render accurate diagnoses and to guide therapy. The basic process by which anatomic pathologists render diagnoses has remained relatively unchanged over the last century, yet advances in information technology now offer significant opportunities in image-based diagnostic and research applications. Pathology has lagged behind other healthcare practices such as radiology where digital adoption is widespread. As devices that generate whole slide images become more practical and affordable, practices will increasingly adopt this technology and eventually produce an explosion of data that will quickly eclipse the already vast quantities of radiology imaging data. These advances are accompanied by significant challenges for data management and storage, but they also introduce new opportunities to improve patient care by streamlining and standardizing diagnostic approaches and uncovering disease mechanisms. Computer-based image analysis is already available in commercial diagnostic systems, but further advances in image analysis algorithms are warranted in order to fully realize the benefits of digital pathology in medical discovery and patient care. In coming decades, pathology image analysis will extend beyond the streamlining of diagnostic workflows and minimizing interobserver variability and will begin to provide diagnostic assistance, identify therapeutic targets, and predict patient outcomes and therapeutic responses. PMID:25328166

... HUMAN SERVICES Food and Drug Administration Public Workshop on MedicalDevices and Nanotechnology...) is announcing a public workshop entitled ``MedicalDevices & Nanotechnology: Manufacturing... brief statement that describes your experience or expertise with nanotechnology. There will be a...

The improvised explosive device (IED), in all its forms, has become the most significant threat to troops operating in Afghanistan and Iraq. These devices range from rudimentary home made explosives to sophisticated weapon systems containing high-grade explosives. Within this broad definition they may be classified as roadside explosives and blast mines, explosive formed pojectile (EFP) devices and suicide bombings. Each of these groups causeinjury through a number of different mechanisms and can result in vastly different injury profiles. The "Global War on Terror" has meant that incidents which were previously exclusively seen in conflict areas, can occur anywhere, and clinicians who are involved in emergency trauma care may be required to manage casualties from similar terrorist attacks. An understanding of the types of devices and their pathophysiological effects is necessary to allow proper planning of mass casualty events and to allow appropriate management of the complex poly-trauma casualties they invariably cause. The aim of this review article is to firstly describe the physics and injury profile from these different devices and secondly to present the current clinical evidence that underpins their medical management. PMID:20397601

Image segmentation plays a crucial role in many medicalimaging applications by automatically locating the regions of interest. Typically supervised learning based segmentation methods require a large set of accurately labeled training data. However, thel labeling process is tedious, time consuming and sometimes not necessary. We propose a robust logistic regression algorithm to handle label outliers such that doctors do not need to waste time on precisely labeling images for training set. To validate its effectiveness and efficiency, we conduct carefully designed experiments on cervigram image segmentation while there exist label outliers. Experimental results show that the proposed robust logistic regression algorithms achieve superior performance compared to previous methods, which validates the benefits of the proposed algorithms. PMID:23286072

In this paper, we describe some central mathematical problems in medicalimaging. The subject has been undergoing rapid changes driven by better hardware and software. Much of the software is based on novel methods utilizing geometric partial differential equations in conjunction with standard signal/image processing techniques as well as computer graphics facilitating man/machine interactions. As part of this enterprise, researchers have been trying to base biomedical engineering principles on rigorous mathematical foundations for the development of software methods to be integrated into complete therapy delivery systems. These systems support the more effective delivery of many image-guided procedures such as radiation therapy, biopsy, and minimally invasive surgery. We will show how mathematics may impact some of the main problems in this area, including image enhancement, registration, and segmentation. PMID:23645963

This paper introduces the current status of Chinese medicaldevice testing and inspection institutes. There are 53 such institutions, including 10 national institutions. Medicaldevice testing and inspection institutions service in government regulation and supervision of medicaldevices, playing a technique support role for medicaldevices from registration before appear on market to monitor and supervision after listing. Meanwhile, they are important practitioners of medicaldevices standardization work. Finally, put forward the current problems and countermeasures of the inspection institutes in order to facilitate the sustainable development of our national medical equipment. PMID:24839853

Cadmium zinc telluride (CdZnTe, or CZT) is a room-temperature semiconductor radiation detector that has been developed in recent years for a variety of applications. CZT has been investigated for many potential uses in medicalimaging, especially in the field of single photon emission computed tomography (SPECT). CZT can also be used in positron emission tomography (PET) as well as photon-counting and integration-mode x-ray radiography and computed tomography (CT). The principal advantages of CZT are 1) direct conversion of x-ray or gamma-ray energy into electron-hole pairs; 2) energy resolution; 3) high spatial resolution and hence high space-bandwidth product; 4) room temperature operation, stable performance, high density, and small volume; 5) depth-of-interaction (DOI) available through signal processing. These advantages will be described in detail with examples from our own CZT systems. The ability to operate at room temperature, combined with DOI and very small pixels, make the use of multiple, stationary CZT "mini-gamma cameras" a realistic alternative to today's large Anger-type cameras that require motion to obtain tomographic sampling. The compatibility of CZT with Magnetic Resonance Imaging (MRI)-fields is demonstrated for a new type of multi-modality medicalimaging, namely SPECT/MRI. For pre-clinical (i.e., laboratory animal) imaging, the advantages of CZT lie in spatial and energy resolution, small volume, automated quality control, and the potential for DOI for parallax removal in pinhole imaging. For clinical imaging, the imaging of radiographically dense breasts with CZT enables scatter rejection and hence improved contrast. Examples of clinical breast images with a dual-head CZT system are shown.

Historically, development of medicalimaging applications has focused on solving technical issues for small numbers of expert users. However, their use is now more mainstream and users are no longer willing to tolerate poor performance and usability. In this study we illustrate the application of user centred design methods in a medicalimaging applications development company by using a usability comparative study of different regions of interest (ROI) tools. A use case analysis was used to judge usability efficiency and effectiveness of different ROI tools; and a user observation was also carried out which measured the accuracy achieved by these tools. We have found that useful results can be obtained by using these methods. We also generated some concrete suggestions that could be incorporated into future product development.

Implantable medicaldevice is a special product which belongs to medicaldevices. It not only possesses product characteristics in common, but also has specificity for safety and effectiveness. Implantable medicaldevice must be managed by the relevant laws and regulations of the State Food and Drug Administration. In this paper, we have used cardiac pacemakers as an example to describe the significance of the management of implantable medicaldevice products and the application of the internet of things in hospitals. PMID:22379772

The Food and Drug Administration (FDA) is reclassifying six cardiovascular pre amendments devices from class III (pre market approval) into class II (special controls). FDA is also identifying the special controls that the agency believes will reasonably ensure the safety and effectiveness of the devices. This reclassification is being undertaken on the agency's own initiative based on new information under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe MedicalDevices Act of 1990 and the Food and Drug Administration Modernization Act of 1997. The agency is also revising the identification of one of the devices subject to this rule to simplify the classification regulation and is correcting a typographical error that was incorporated into the regulations. PMID:11721689

The large volume of data captured daily in healthcare institutions is opening new and great perspectives about the best ways to use it towards improving clinical practice. In this paper we present a context-based recommender system to support medicalimaging diagnostic. The system relies on data mining and context-based retrieval techniques to automatically lookup for relevant information that may help physicians in the diagnostic decision. PMID:25991188

Health technology assessment (HTA) is a rapidly developing area and the value of taking non-clinical fields into consideration is growing. Although the health-economic aspect is commonly recognised, evaluating organisational impact has not been studied nearly as much. The goal of this work was to provide a definition of organisational impact in the sector of medicaldevices by defining its contours and exploring the evaluation methods specific to this field. Following an analysis of the literature concerning the impact of technologies on organisations as well as the medical literature, and also after reviewing the regulatory texts in this respect, the group of experts identified 12 types of organisational impact. A number of medicaldevices were carefully screened using the criteria grid, which proved to be operational and to differentiate properly. From the analysis of the practice and of the methods described, the group was then able to derive a few guidelines to successfully evaluate organisational impact. This work shows that taking organisational impact into consideration may be critical alongside of the other criteria currently in favour (clinically and economically). What remains is to confer a role in the decision-making process on this factor and one that meets the economic efficiency principle. PMID:27080633

... extension for a medicaldevice. 1.777 Section 1.777 Patents, Trademarks, and Copyrights UNITED STATES PATENT... term extension for a medicaldevice. (a) If a determination is made pursuant to § 1.750 that a patent for a medicaldevice is eligible for extension, the term shall be extended by the time as...

... extension for a medicaldevice. 1.777 Section 1.777 Patents, Trademarks, and Copyrights UNITED STATES PATENT... term extension for a medicaldevice. (a) If a determination is made pursuant to § 1.750 that a patent for a medicaldevice is eligible for extension, the term shall be extended by the time as...

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medicaldevices for use in teaching, law..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICALDEVICES LABELING Exemptions From Adequate Directions for Use § 801.125 Medicaldevices for use in teaching, law enforcement, research, and analysis....

... HUMAN SERVICES Food and Drug Administration Dental Products Panel of the MedicalDevices Advisory... MedicalDevices Advisory Committee. This meeting was announced in the Federal Register of June 11, 2010... announced that a meeting of the Dental Products Panel of the MedicalDevices Advisory Committee would...

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medicaldevices for use in teaching, law..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICALDEVICES LABELING Exemptions From Adequate Directions for Use § 801.125 Medicaldevices for use in teaching, law enforcement, research, and analysis....

... extension for a medicaldevice. 1.777 Section 1.777 Patents, Trademarks, and Copyrights UNITED STATES PATENT... term extension for a medicaldevice. (a) If a determination is made pursuant to § 1.750 that a patent... patent for a medicaldevice will be extended by the length of the regulatory review period for...

... extension for a medicaldevice. 1.777 Section 1.777 Patents, Trademarks, and Copyrights UNITED STATES PATENT... term extension for a medicaldevice. (a) If a determination is made pursuant to § 1.750 that a patent... patent for a medicaldevice will be extended by the length of the regulatory review period for...

... HUMAN SERVICES Food and Drug Administration Extreme Weather Effects on MedicalDevice Safety and Quality... medicaldevice safety and quality. FDA is announcing at this time its request for comments on the topic of extreme weather effects on medicaldevice safety and quality. DATES: Submit either electronic or...

Medicalimaging research depends basically on the availability of large image collections, image processing and analysis algorithms, hardware and a multidisciplinary research team. It has to be reproducible, free of errors, fast, accessible through a large variety of devices spread around research centers and conducted simultaneously by a multidisciplinary team. Therefore, we propose a collaborative research environment, named Adessowiki, where tools and datasets are integrated and readily available in the Internet through a web browser. Moreover, processing history and all intermediate results are stored and displayed in automatic generated web pages for each object in the research project or clinical study. It requires no installation or configuration from the client side and offers centralized tools and specialized hardware resources, since processing takes place in the cloud.

This paper analyzes the feasibility and performance of HSI systems for medical diagnosis as well as for food safety. Illness prevention and early disease detection are key elements for maintaining good health. Health care practitioners worldwide rely on innovative electronic devices to accurately identify disease. Hyperspectral imaging (HSI) is an emerging technique that may provide a less invasive procedure than conventional diagnostic imaging. By analyzing reflected and fluorescent light applied to the human body, a HSI system serves as a diagnostic tool as well as a method for evaluating the effectiveness of applied therapies. The safe supply and production of food is also of paramount importance to public health illness prevention. Although this paper will focus on imaging and spectroscopy in food inspection procedures -- the detection of contaminated food sources -- to ensure food quality, HSI also shows promise in detecting pesticide levels in food production (agriculture.)

We present a medical workstation for the efficient implementation of research ideas related to image processing and computer graphics. Based on standard hardware platforms the software system encompasses two major components: A turnkey application system provides a functionally kernel for a broad community of clinical users working with digital imagingdevices, including methods of noise suppression, interactive and automatic segmentation, 3D surface reconstruction and multi-modal registration. A development toolbox allows new algorithms and applications to be efficiently implemented and consistently integrated with the common framework of the turnkey system. The platform is based on an elaborate object class structure describing objects for image processing, computer graphics, study handling and user interface control. Thus expertise of computer scientists familiar with this application domain is brought into the hospital and can be readily used by clinical researchers. PMID:7850734

The present invention is directed to devices and systems used in magnetic imaging environments that include an actuator device having an elastomeric dielectric film with at least two electrodes, and a frame attached to the actuator device. The frame can have a plurality of configurations including, such as, for example, at least two members that can be, but not limited to, curved beams, rods, plates, or parallel beams. These rigid members can be coupled to flexible members such as, for example, links wherein the frame provides an elastic restoring force. The frame preferably provides a linear actuation force characteristic over a displacement range. The linear actuation force characteristic is defined as .+-.20% and preferably 10% over a displacement range. The actuator further includes a passive element disposed between the flexible members to tune a stiffness characteristic of the actuator. The passive element can be a bi-stable element. The preferred embodiment actuator includes one or more layers of the elastomeric film integrated into the frame. The elastomeric film can be made of many elastomeric materials such as, for example, but not limited to, acrylic, silicone and latex.

Sandia National Laboratories is developing a new form of flexural plate wave device (FPW) for sensor applications. In this device, Lorentz forces cause out of plane vibrations in a silicon nitride membrane. Current induced in transducer lines on the membrane provides information about the amplitude and phase of these surface vibrations. By tracking the large amplitude vibrations that occur at resonant frequencies, it is possible to infer information about loading on the membrane. In fabricating FPWs, it is important to understand the impact that minor defects can have on operation. Through modeling and testing, they are developing resilient designs that provide large amplitude signals with a high tolerance to defects. A finite element model has been developed to perform design trade-off studies, and results from the model are being verified with a unique measurement system that can image Angstrom scale displacements at vibrational frequencies up to 800 kHz. Results from FPW modeling and imaging efforts are presented in this paper.

The Internet has established itself as an affordable, extremely viable and ubiquitous communications network that can be easily accessed from virtually any point in the world. This makes it ideally suited for medicalimage communications. Issues regarding security and confidentiality of information on the Internet, however, need to be addressed for both occasional, individual users and consistent enterprise-wide users. In addition, the limited bandwidth of most Internet connections must be factored into the development of a realistic usermodel and resulting protocol. Open architecture issues must also be considered so that images can be communicated to recipients who do not have similar programs. Further, application-specific software is required to integrate image acquisition, encryption and transmission into a single, streamlined process. Using Photomailer software provided by PhysiTel Inc., the authors investigated the use of sending secured still images over the Internet. The scope of their investigation covered the use of the Internet for communicating images for consultation, referral, mentoring and education. Photomailer software was used at several local and remote sites. The program was used for both sending and receiving images. It was also used for sending images to recipients who did not have Photomailer, but instead relied on conventional email programs. The results of the investigation demonstrated that using products such as Photomailer, images could be quickly and easily communicated from one location to another via the Internet. In addition, the investigators were able to retrieve images off of their existing email accounts, thereby providing greater flexibility and convenience than other systems which require scheduled transmission of information on dedicated systems. We conclude that Photomailer and similar products may provide a significant benefit and improve communications among colleagues, providing an inexpensive means of sending secured

Medicaldevices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion. PMID:25747839

Several electronic devices for automatically correcting specific defects in a body's physiologic regulation and allowing approximately normal functioning are described. A self-injurious behavior inhibiting system (SIBIS) is fastened to the arm of a person with chronic self-injurious behavior patterns. An electric shock is delivered into the arm whenever the device senses above-threshold acceleration of the head such as occur with head-bangers. Sounding a buzzer tone with the shock eventually allows transference of the aversive stimulus to the buzzer so shocks are no longer necessary. A programmable implantable medication system features a solenoid pump placed beneath the skin and refueled by hypodermic needle. The pump functions are programmable and can deliver insulin, chemotherapy mixes and/or pain killers according to a preset schedule or on patient demand. Finally, an automatic implantible defibrillator has four electrodes attached directly to the heart for sensing electrical impulses or emitting them in response to cardiac fibrillation.

The past fifty years has witnessed dramatic progress in the understanding and treatment of patients suffering from cardiovascular disease leading to symptomatic relief and impressive increases in longevity. These advances have been due in large part to the development, study and implementation of new technology. Within interventional cardiology in particular, these advances have been driven by the availability of new technology in the form of medicaldevices. Successful device development efforts require close collaboration among basic scientist, clinician-inventors/entrepreneurs, clinician-investigators and corporations. Though the role of the clinician is central to this process, these activities present important conflicts-of-interest (COIs). The purpose of this paper is to 1) characterize these conflicts, 2) provide a context from which to approach their management and 3) recommend management strategies. PMID:23217436

Validation by steam sterilization of reusable medicaldevices requires careful attention to many parameters that directly influence whether or not complete sterilization occurs. Complex implant/instrument tray systems have a variety of configurations and components. Geobacillus stearothermophilus biological indicators (BIs) are used in overkill cycles to to simulate worst case conditions and are intended to provide substantial sterilization assurance. Survival of G. stearothermophilus spores was linked to steam access and size of load in the chamber. By a small and reproducible margin, it was determined that placement of the trays in a rigid container into minimally loaded chambers were more difficult to completely sterilize than maximally loaded chambers. PMID:25046511

...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``MedicalDevice Classification Product Codes.'' This document describes how device product codes are used in a variety of FDA program areas to regulate and track medicaldevices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research......

A study was undertaken to evaluate different procedures to safely remove microorganisms, protein, and mammalian cells from materials and provide a suitable method for cleaning and assessing effectiveness of cleaning medicaldevices for reuse or for analysis of failure. Safety considerations for the personnel performing the cleaning or handling the device after cleaning are important issues. Polystyrene plates (96 well) were used to simulate device surfaces not amenable to manual scrubbing. Staphylococcus epidermidis, Candida albicans, Escherichia coli, Pseudomonas aeruginosa, and oral flora were grown in the plates. The plates were stained with crystal violet and the optical densities recorded. The results indicated that E. coli did not adhere well and Pseudomonas formed clumps that were easily detached from the surface of the plates. However, S. epi, C. albicans, and the oral organisms formed adherent biofilms that were difficult to remove from the plates. Detergents with enzymes and sodium hypochlorite (NaOCl) bleach were both effective in removing the biofilm. Other detergents and surfactants were not effective. The aldehyde agents did not remove the organisms and made further cleaning difficult. Allowing the biofilm to dry first made cleaning very difficult. Only the NaOCl bleach could subsequently remove the dried or aldehyde fixed organisms from the wells. The same 96-well polystyrene plate format was used to measure the amount of protein and cell adherence as well as the effectiveness of subsequent cleaning. Bradford reagent was used to detect protein as a measure of the cleaning efficacy. As with the bacteria, NaOCl bleach was effective at removing the protein and cells that had been dried or fixed by formalin or alcohol, whereas detergent with enzymes was not very effective. This study confirmed that used medicaldevices, contaminated with microorganisms, protein, and/or mammalian cells, should not be allowed to dry before cleaning and that a thorough

This paper presents a novel optical angiography system, and introduces its medical applications. We developed the optical enhanced imaging system which can observe the blood and lymphatic vessels as the Indocyanine green (ICG) fluorescence image. The imaging system consists of 760nm light emitted diode (LED) as excite light, CCD camera as a detector, a high-pass optical filter in front of the CCD and video processing system. The advantage of ICG fluorescence method is safe (radiation free), high sensitive, real time monitoring of blood and/or lymphatic flow, small size, easy to operate and cost effective compared to conventional X-ray angiography or scintigraphy. We have applied this method to several clinical applications such as breast cancer sentinel lymph node (SLN) navigation, lymph edema diagnostic and identification of liver segmentation. In each application, ICG fluorescence method shows useful result. It's indicated that this method is promising technique as optical angiography.

This article focuses on standards supporting interoperability and system integration in the medicalimaging domain. We introduce the basic concepts and actors and we review the most salient achievements in this domain, especially with the DICOM standard, and the definition of IHE integration profiles. We analyze and discuss what was successful, and what could still be more widely adopted by industry. We then sketch out a perspective of what should be done next, based on our vision of new requirements for the next decade. In particular, we discuss the challenges of a more explicit sharing of image and image processing semantics, and we discuss the help that semantic web technologies (and especially ontologies) may bring to achieving this goal. PMID:20605693

Background There has been much recent interest in the quantification of visually evident heterogeneity within functional grayscale medicalimages, such as those obtained via magnetic resonance or positron emission tomography. In the case of images of cancerous tumors, variations in grayscale intensity imply variations in crucial tumor biology. Despite these considerable clinical implications, there is as yet no standardized method for measuring the heterogeneity observed via these imaging modalities. Methods In this work, we motivate and derive a statistical measure of image heterogeneity. This statistic measures the distance-dependent average deviation from the smoothest intensity gradation feasible. We show how this statistic may be used to automatically rank images of in vivo human tumors in order of increasing heterogeneity. We test this method against the current practice of ranking images via expert visual inspection. Results We find that this statistic provides a means of heterogeneity quantification beyond that given by other statistics traditionally used for the same purpose. We demonstrate the effect of tumor shape upon our ranking method and find the method applicable to a wide variety of clinically relevant tumor images. We find that the automated heterogeneity rankings agree very closely with those performed visually by experts. Conclusions These results indicate that our automated method may be used reliably to rank, in order of increasing heterogeneity, tumor images whether or not object shape is considered to contribute to that heterogeneity. Automated heterogeneity ranking yields objective results which are more consistent than visual rankings. Reducing variability in image interpretation will enable more researchers to better study potential clinical implications of observed tumor heterogeneity. PMID:23453000

In this paper, we propose a new method for improving the performance of 2D descriptors by building an n-layer image using different preprocessing approaches from which multilayer descriptors are extracted and used as feature vectors for training a Support Vector Machine. The different preprocessing approaches are used to build different n-layer images (n=3, n=5, etc.). We test both color and gray-level images, two well-known texture descriptors (Local Phase Quantization and Local Binary Pattern), and three of their variants suited for n-layer images (Volume Local Phase Quantization, Local Phase Quantization Three-Orthogonal-Planes, and Volume Local Binary Patterns). Our results show that multilayers and texture descriptors can be combined to outperform the standard single-layer approaches. Experiments on 10 datasets demonstrate the generalizability of the proposed descriptors. Most of these datasets are medical, but in each case the images are very different. Two datasets are completely unrelated to medicine and are included to demonstrate the discriminative power of the proposed descriptors across very different image recognition tasks. A MATLAB version of the complete system developed in this paper will be made available at https://www.dei.unipd.it/node/2357. PMID:26656952

This paper presents as new approach to image recognition based on a general attraction principle. A cognitive recognition is governed by a 'focus on attention' process that concentrates on the visual data subset of task- relevant type only. Our model-based approach combines it with another process, focus on attraction, which concentrates on the transformations of visual data having relevance for the matching. The recognition process is characterized by an intentional evolution of the visual data. This chain of image transformations is viewed as driven by an attraction field that attempts to reduce the distance between the image-point and the model-point in the feature space. The field sources are determined during a learning phase, by supplying the system with a training set. The paper describes a medical interpretation case in the feature space, concerning human skin lesions. The samples of the training set, supplied by the dermatologists, allow the system to learn models of lesions in terms of features such as hue factor, asymmetry factor, and asperity factor. The comparison of the visual data with the model derives the trend of image transformations, allowing a better definition of the given image and its classification. The algorithms are implemented in C language on a PC equipped with Matrox Image Series IM-1280 acquisition and processing boards. The work is now in progress.

... bandwidth of an imaging system operating under the provisions of this section must be contained between 3100 MHz and 10,600 MHz. (b) Operation under the provisions of this section is limited to medicalimaging... radiated emissions at or below 960 MHz from a device operating under the provisions......

... bandwidth of an imaging system operating under the provisions of this section must be contained between 3100 MHz and 10,600 MHz. (b) Operation under the provisions of this section is limited to medicalimaging... radiated emissions at or below 960 MHz from a device operating under the provisions......

... bandwidth of an imaging system operating under the provisions of this section must be contained between 3100 MHz and 10,600 MHz. (b) Operation under the provisions of this section is limited to medicalimaging... radiated emissions at or below 960 MHz from a device operating under the provisions......

... bandwidth of an imaging system operating under the provisions of this section must be contained between 3100 MHz and 10,600 MHz. (b) Operation under the provisions of this section is limited to medicalimaging... radiated emissions at or below 960 MHz from a device operating under the provisions......

Objective The study tested the performance of adverse effects search filters when searching for safety information on medicaldevices, procedures, and diagnostic tests in MEDLINE and Embase. Methods The sensitivity of 3 filters was determined using a sample of 631 references from 131 rapid reviews related to the safety of health technologies. The references were divided into 2 sets by type of intervention: drugs and nondrug health technologies. Keyword and indexing analysis were performed on references from the nondrug testing set that 1 or more of the filters did not retrieve. Results For all 3 filters, sensitivity was lower for nondrug health technologies (ranging from 53%–87%) than for drugs (88%–93%) in both databases. When tested on the nondrug health technologies set, sensitivity was lower in Embase (ranging from 53%–81%) than in MEDLINE (67%–87%) for all filters. Of the nondrug records that 1 or more of the filters missed, 39% of the missed MEDLINE records and 18% of the missed Embase records did not contain any indexing terms related to adverse events. Analyzing the titles and abstracts of nondrug records that were missed by any 1 filter, the most commonly used keywords related to adverse effects were: risk, complications, mortality, contamination, hemorrhage, and failure. Conclusions In this study, adverse effects filters were less effective at finding information about the safety of medicaldevices, procedures, and tests compared to information about the safety of drugs. PMID:27366123

We realize a thermally stable polymer thin film transistor (TFT) that is able to endure the standard autoclave sterilization for reusable medicaldevices. A thermally stable semiconducting polymer poly[4-(4,4-dihexadecyl-4Hcyclopenta[1,2-b:5,4-b]dithiophen-2-yl)-alt[1,2,5]thiadiazolo [3,4c] pyridine], which is stable up to 350 °C in N2 and 200 °C in air, is used as channel layer, whereas the biocompatible SU-8 polymer is used as a flexible dielectric layer, in addition to conventional SiO2 dielectric layer. Encapsulating with in-house designed composite film laminates as moisture barrier, both TFTs using either SiO2 or SU-8 dielectric layer exhibit good stability in sterilized conditions without significant change in mobility and threshold voltage. After sterilization for 30 min in autoclave, the mobility drops only 15%; from as-fabricated mobility of 1.4 and 1.3 cm(2) V(-1) s(-1) to 1.2 and 1.1 cm(2) V(-1) s(-1) for TFTs with SiO2 and SU-8 dielectric layer, respectively. Our TFT design along with experimental results reveal the opportunity on organic/polymer flexible TFTs in sterilizable/reusable medicaldevice application. PMID:27039992

Currently, hyperthermic-based minimally invasive medicaldevices are available for the treatment of dysfunctional and neoplastic tissues in a variety of organ systems. These therapies employ a spectrum of modalities for delivering heat energy to the targeted tissue, including radiofrequency/microwave, high intensity focused ultrasound, conductive/convective sources and others. While differences in energy transfer and organ systems exist, hyperthermic treatment sites show a spectrum of changes that intimately correlate with the thermal history generated in the tissue (temperature-time dependence). As a result, these hyperthermic medical technologies can be viewed using a "gradient" approach. First, the thermal applications themselves can be globally categorized along a high-dose ablation to low-dose ablation to lowdose non-ablative rejuvenating slope. Second, the resultant tissue changes can be viewed along a decreasing thermal dose gradient from thermally/heat-fixed tissue necrosis to coagulative tissue necrosis to partial tissue necrosis (transition zone) to subtle non-necrotizing tissue changes. Finally, a gradient of cellular and structural protein denaturation is present, especially within the transition zone and adjacent viable tissue region. A hyperthermic treatment's location along these gradients depends more on the overall thermal history it generates than the amount of energy it deposits into the tissue. The features of these gradients are highlighted to provide a better understanding of hyperthermic device associated tissue changes and their associated healing responses.

Ultrasound medical (US) imaging non-invasively pictures inside of a human body for disease diagnostics. Speckle noise attacks ultrasound images degrading their visual quality. A twofold processing algorithm is proposed in this work to reduce this multiplicative speckle noise. First fold used block based thresholding, both hard (BHT) and soft (BST), on pixels in wavelet domain with 8, 16, 32 and 64 non-overlapping block sizes. This first fold process is a better denoising method for reducing speckle and also inducing object of interest blurring. The second fold process initiates to restore object boundaries and texture with adaptive wavelet fusion. The degraded object restoration in block thresholded US image is carried through wavelet coefficient fusion of object in original US mage and block thresholded US image. Fusion rules and wavelet decomposition levels are made adaptive for each block using gradient histograms with normalized differential mean (NDF) to introduce highest level of contrast between the denoised pixels and the object pixels in the resultant image. Thus the proposed twofold methods are named as adaptive NDF block fusion with hard and soft thresholding (ANBF-HT and ANBF-ST). The results indicate visual quality improvement to an interesting level with the proposed twofold processing, where the first fold removes noise and second fold restores object properties. Peak signal to noise ratio (PSNR), normalized cross correlation coefficient (NCC), edge strength (ES), image quality Index (IQI) and structural similarity index (SSIM), measure the quantitative quality of the twofold processing technique. Validation of the proposed method is done by comparing with anisotropic diffusion (AD), total variational filtering (TVF) and empirical mode decomposition (EMD) for enhancement of US images. The US images are provided by AMMA hospital radiology labs at Vijayawada, India. PMID:26697285

A workstation has been developed to evaluate computed tomographic (CT) image data in 2 and 3 dimensions. The workstation consists of an independent image display station (Independent Viewing and Analysis Station or WAS, International Imaging Systems, Inc., Milpitas, Calif.) and a VAX host computer. The WAS has 1024 X 1024 X 24 bits of image memory plus 4 bits of graphics overlay. An independent VLSI graphics processor and 1024 X 1024 X 4 bit graphics memory, independent of the image memory, are included in the self-contained WAS unit. A local microprocessor host (Motorola 68000 microprocessor) controls the IVAS from directives obtained through a direct memory access channel to the VAX host. This facilitated the creation of an object oriented software enviroment for the IVAS under control of a VAX host program written in the C language. The workstation created has an interactive user interface consisting of a mouse and pull-down menus. The workstation enables loading multiple images, typically 256 x 256 or 512 x 512, into the 1024 X 1024 frame buffer. Once loaded, the images can be manipulated by applying gray scale transforms, editing them and performing 3-D reconstructions from serial sections. Algorithms for three dimensional (3-D) reconstructions were implemented in the VAX/VMS host computer environment and are available on the workstation through special menu functions for handling these reconstructions. The functions interactively combine depth and gradient shading of surfaces to suit specific applications in craniofacial surgical planning or orthopedics. This workstation is user friendly and is very easy to handle. A workstation of this type may become a popular tool for physicians and surgeons in evalution of medicalimages.

It is a well known fact that managed care and new treatment technologies are revolutionizing the health care provider world. Community Health Information Network and Computer-based Patient Record projects are underway throughout the United States. More and more hospitals are installing digital, `filmless' radiology (and other imagery) systems. They generate a staggering amount of information around the clock. For example, a typical 500-bed hospital might accumulate more than 5 terabytes of image data in a period of 30 years for conventional x-ray images and digital images such as Magnetic Resonance Imaging and Computer Tomography images. With several hospitals contributing to the archive, the storage required will be in the hundreds of terabytes. Systems for reliable, secure, and inexpensive storage and retrieval of digital medical information do not exist today. In this paper, we present a MedicalImage Archive and Distribution Service (MIADS) concept. MIADS is a system shared by individual and community hospitals, laboratories, and doctors' offices that need to store and retrieve medicalimages. Due to the large volume and complexity of the data, as well as the diversified user access requirement, implementation of the MIADS will be a complex procedure. One of the key challenges to implementing a MIADS is to select a cost-effective, scalable system architecture to meet the ingest/retrieval performance requirements. We have performed an in-depth system engineering study, and developed a sophisticated simulation model to address this key challenge. This paper describes the overall system architecture based on our system engineering study and simulation results. In particular, we will emphasize system scalability and upgradability issues. Furthermore, we will discuss our simulation results in detail. The simulations study the ingest/retrieval performance requirements based on different system configurations and architectures for variables such as workload, tape

Digital Imaging Processing (DIP) requires data extraction and output from a visualization tool to be consistent. Data handling and transmission between the server and a user is a systematic process in service interpretation. The use of integrated medical services for management and viewing of imaging data in combination with a mobile visualization tool can be greatly facilitated by data analysis and interpretation. This paper presents an integrated mobile application and DIP service, called M-DIP. The objective of the system is to (1) automate the direct data tiling, conversion, pre-tiling of brain images from MedicalImaging NetCDF (MINC), Neuroimaging Informatics Technology Initiative (NIFTI) to RAW formats; (2) speed up querying of imaging measurement; and (3) display high-level of images with three dimensions in real world coordinates. In addition, M-DIP provides the ability to work on a mobile or tablet device without any software installation using web-based protocols. M-DIP implements three levels of architecture with a relational middle-layer database, a stand-alone DIP server, and a mobile application logic middle level realizing user interpretation for direct querying and communication. This imaging software has the ability to display biological imaging data at multiple zoom levels and to increase its quality to meet users’ expectations. Interpretation of bioimaging data is facilitated by an interface analogous to online mapping services using real world coordinate browsing. This allows mobile devices to display multiple datasets simultaneously from a remote site. M-DIP can be used as a measurement repository that can be accessed by any network environment, such as a portable mobile or tablet device. In addition, this system and combination with mobile applications are establishing a virtualization tool in the neuroinformatics field to speed interpretation services. PMID:23847587

Digital Imaging Processing (DIP) requires data extraction and output from a visualization tool to be consistent. Data handling and transmission between the server and a user is a systematic process in service interpretation. The use of integrated medical services for management and viewing of imaging data in combination with a mobile visualization tool can be greatly facilitated by data analysis and interpretation. This paper presents an integrated mobile application and DIP service, called M-DIP. The objective of the system is to (1) automate the direct data tiling, conversion, pre-tiling of brain images from MedicalImaging NetCDF (MINC), Neuroimaging Informatics Technology Initiative (NIFTI) to RAW formats; (2) speed up querying of imaging measurement; and (3) display high-level of images with three dimensions in real world coordinates. In addition, M-DIP provides the ability to work on a mobile or tablet device without any software installation using web-based protocols. M-DIP implements three levels of architecture with a relational middle-layer database, a stand-alone DIP server, and a mobile application logic middle level realizing user interpretation for direct querying and communication. This imaging software has the ability to display biological imaging data at multiple zoom levels and to increase its quality to meet users' expectations. Interpretation of bioimaging data is facilitated by an interface analogous to online mapping services using real world coordinate browsing. This allows mobile devices to display multiple datasets simultaneously from a remote site. M-DIP can be used as a measurement repository that can be accessed by any network environment, such as a portable mobile or tablet device. In addition, this system and combination with mobile applications are establishing a virtualization tool in the neuroinformatics field to speed interpretation services. PMID:23847587

Healthcare systems are subject to continuous adaptation, following trends such as the change of demographic structures, the rise of life-style related and chronic diseases, and the need for efficient and outcome-oriented procedures. This also influences the design of new imaging systems as well as their components. The applications of X-ray imaging in the medical field are manifold and have led to dedicated modalities supporting specific imaging requirements, for example in computed tomography (CT), radiography, angiography, surgery or mammography, delivering projection or volumetric imaging data. Depending on the clinical needs, some X-ray systems enable diagnostic imaging while others support interventional procedures. X-ray detector design requirements for the different medical applications can vary strongly with respect to size and shape, spatial resolution, frame rates and X-ray flux, among others. Today, integrating X-ray detectors are in common use. They are predominantly based on scintillators (e.g. CsI or Gd2O2S) and arrays of photodiodes made from crystalline silicon (Si) or amorphous silicon (a-Si) or they employ semiconductors (e.g. Se) with active a-Si readout matrices. Ongoing and future developments of X-ray detectors will include optimization of current state-of-the-art integrating detectors in terms of performance and cost, will enable the usage of large size CMOS-based detectors, and may facilitate photon counting techniques with the potential to further enhance performance characteristics and foster the prospect of new clinical applications.

The healthcare industry is recently going through extensive changes, through adoption of robust, interoperable healthcare information technology by means of electronic medical records (EMR). However, a major concern of EMR is adequate confidentiality of the individual records being managed electronically. Multiple access points over an open network like the Internet increases possible patient data interception. The obligation is on healthcare providers to procure information security solutions that do not hamper patient care while still providing the confidentiality of patient information. Medicalimages are also part of the EMR which need to be protected from unauthorized users. This study integrates the techniques of fingerprint verification, DICOM object, digital signature and digital envelope in order to ensure that access to the hospital Picture Archiving and Communication System (PACS) or radiology information system (RIS) is only by certified parties. PMID:18178287

Displaytech Inc., based in Longmont, Colorado and recently acquired by Micron Technology Inc. of Boise, Idaho, first received a Small Business Innovation Research contract in 1993 from Johnson Space Center to develop tiny, electronic, color displays, called microdisplays. Displaytech has since sold over 20 million microdisplays and was ranked one of the fastest growing technology companies by Deloitte and Touche in 2005. Customers currently incorporate the microdisplays in tiny pico-projectors, which weigh only a few ounces and attach to media players, cell phones, and other devices. The projectors can convert a digital image from the typical postage stamp size into a bright, clear, four-foot projection. The company believes sales of this type of pico-projector may exceed $1.1 billion within 5 years.

A number of medicalimaging techniques are used heavily in the provision of spatially resolved information on disease and physiological status and accordingly play a critical role in clinical diagnostics and subsequent treatment. Though, for most imaging modes, contrast is potentially enhanced through the use of contrast agents or improved hardware or imaging protocols, no single methodology provides, in isolation, a detailed mapping of anatomy, disease markers or physiological status. In recent years, the concept of complementing the strengths of one imaging modality with those of another has come to the fore and been further bolstered by the development of fused instruments such as PET/CT and PET/MRI stations. Coupled with the continual development in imaging hardware has been a surge in reports of contrast agents bearing multiple functionality, potentially providing not only a powerful and highly sensitised means of co-localising physiological/disease status and anatomy, but also the tracking and delineation of multiple markers and indeed subsequent or simultaneous highly localized therapy (“theragnostics”). PMID:21409202

A new coding scheme based on the scalar-vector quantizer (SVQ) is developed for compression of medicalimages. The SVQ is a fixed rate encoder and its rate-distortion performance is close to that of optimal entropy-constrained scalar quantizers (ECSQs) for memoryless sources. The use of a fixed-rate quantizer is expected to eliminate some of the complexity of using variable-length scalar quantizers. When transmission of images over noisy channels is considered, our coding scheme does not suffer from error propagation that is typical of coding schemes using variable-length codes. For a set of magnetic resonance (MR) images, coding results obtained from SVQ and ECSQ at low bit rates are indistinguishable. Furthermore, our encoded images are perceptually indistinguishable from the original when displayed on a monitor. This makes our SVQ-based coder an attractive compression scheme for picture archiving and communication systems (PACS). PACS are currently under study for use in an all-digital radiology environment in hospitals, where reliable transmission, storage, and high fidelity reconstruction of images are desired. PMID:18285124

Medicalimage segmentation is nowadays required for medicaldevice development and in a growing number of clinical and research applications. Since dedicated automatic segmentation methods are not always available, generic and efficient interactive tools can alleviate the burden of manual segmentation. In this paper we propose an interactive segmentation tool based on image warping and minimal path segmentation that is efficient for a wide variety of segmentation tasks. While the user roughly delineates the desired organs boundary, a narrow band along the cursors path is straightened, providing an ideal subspace for feature aligned filtering and minimal path algorithm. Once the segmentation is performed on the narrow band, the path is warped back onto the original image, precisely delineating the desired structure. This tool was found to have a highly intuitive dynamic behavior. It is especially efficient against misleading edges and required only coarse interaction from the user to achieve good precision. The proposed segmentation method was tested for 10 difficult liver segmentations on CT and MRI images, and the resulting 2D overlap Dice coefficient was 99% on average..

Background It is well established that considering users is an important aspect of medicaldevice development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. Methods A case study of the development of a new medicalimagingdevice was conducted to examine in detail how users were involved in a medicaldevice development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. Results A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. Conclusion There are a range of informal and formal organisational processes that can affect the uptake of user data during medicaldevice development. Adopting formal decision making processes may assist

Objective The aims of this study were to describe the experiences of senior students using mobile devices in a clinical setting while learning and interacting with clinical teachers, patients and each other, and to identify challenges that facilitated or impeded the use of such devices in the hospital. Design Interpretative phenomenology was chosen to guide our enquiry. Semi-structured interviews were conducted to examine the experiences of five senior medical students using mobile devices in the clinical setting. Setting and participants Senior medical students at an international medical school in the Middle East. Results Three main themes emerged from the data analysis: learning; professional identity and transitioning from student to doctor. The findings showed that using mobile devices in the clinical area as a learning tool was not a formalised process. Rather, it was opportunistic learning at the bedside and on occasion a source of distraction from clinical teaching. Students needed to negotiate relationships between themselves, the clinical teacher and patients in order to ensure that they maintained an acceptable professional image. Participants experienced and negotiated the change from student to doctor making them mindful of using their devices at the bedside. Conclusions Mobile devices are part of daily life for a medical student and there is a need to adapt medical education in the clinical setting, to allow the students to use their devices in a sensitive manner. PMID:27142860

Grid computing, the collaboration of distributed resources across institutional borders, is an emerging technology to meet the rising demand on computing power and storage capacity in fields such as high-energy physics, climate modeling, or more recently, life sciences. A secure, reliable, and highly efficient data transport plays an integral role in such grid environments and even more so in medical grids. Unfortunately, many grid middleware distributions, such as the well-known Globus Toolkit, lack the integration of the world-wide medicalimage communication standard Digital Imaging and Communication in Medicine (DICOM). Currently, the DICOM protocol first needs to be converted to the file transfer protocol (FTP) that is offered by the grid middleware. This effectively reduces most of the advantages and security an integrated network of DICOM devices offers. In this paper, a solution is proposed that adapts the DICOM protocol to the Globus grid security infrastructure and utilizes routers to transparently route traffic to and from DICOM systems. Thus, all legacy DICOM devices can be seamlessly integrated into the grid without modifications. A prototype of the grid routers with the most important DICOM functionality has been developed and successfully tested in the MediGRID test bed, the German grid project for life sciences. PMID:18348944

This article discusses the application of machine learning for the analysis of medicalimages. Specifically: (i) We show how a special type of learning models can be thought of as automatically optimized, hierarchically-structured, rule-based algorithms, and (ii) We discuss how the issue of collecting large labelled datasets applies to both conventional algorithms as well as machine learning techniques. The size of the training database is a function of model complexity rather than a characteristic of machine learning methods. PMID:27374127

Integrated wavelets are a new method for discretizing the continuous wavelet transform (CWT). Independent of the choice of discrete scale and orientation parameters they yield tight families of convolution operators. Thus these families can easily be adapted to specific problems. After presenting the fundamental ideas, we focus primarily on the construction of directional integrated wavelets and their application to medicalimages. We state an exact algorithm for implementing this transform and present applications from the field of digital mammography. The first application covers the enhancement of microcalcifications in digital mammograms. Further, we exploit the directional information provided by integrated wavelets for better separation of microcalcifications from similar structures.

We have developed an automated, wide-field optical coherence tomography (OCT)-based imagingdevice (OTISTM Perimeter MedicalImaging) for peri-operative, ex-vivo tissue imaging. This device features automated image acquisition, enabling rapid capture of high-resolution (15 μm) OCT images from samples up to 10 cm in diameter. We report on the iterative progression of device development from phantom and pre-clinical (tumor xenograft) models through to initial clinical results. We discuss the challenges associated with proving a novel imaging technology against the clinical "gold standard" of conventional post-operative pathology.

Medicalimage processing provides core innovation for medicalimaging. This paper is focused on recent developments from science to applications analyzing the past fifteen years of history of the proceedings of the German annual meeting on medicalimage processing (BVM). Furthermore, some members of the program committee present their personal points of views: (i) multi-modality for imaging and diagnosis, (ii) analysis of diffusion-weighted imaging, (iii) model-based image analysis, (iv) registration of section images, (v) from images to information in digital endoscopy, and (vi) virtual reality and robotics. Medicalimaging and medicalimage computing is seen as field of rapid development with clear trends to integrated applications in diagnostics, treatment planning and treatment. PMID:24078804

An invention relating to the use of a standing acoustic wave charge storage device as an image readout device is described. A frequency f sub 1 was applied to the storage transfer device to create a traveling electric field in the device in one direction along a straight line. A second frequency f sub 2 was applied to the charge transfer device to create a traveling electric field opposite to the first traveling electric field. A standing wave was created. When an image was focused on the charge transfer device, light was stored in the wells of the standing wave. When the frequency f sub 2 is removed from the device, the standing wave tends to break up and the charges stored move to an electrode connected to an output terminal and to a utilization device where the received charges represent the image on the surface of the charge transfer device along a projection of said straight line.